FrancophonIA/ELRC3.0 huggingface dataset:
English: Persistence of immune response and booster response in children 2 to 10 years of age Antibody persistence at 5 years after primary vaccination was assessed in study V59P20E1, this was an extension of study V59P20.
Estonian: Uuringus V59P20E1 uuriti antikehade püsivust 5. aastal pärast esmast vaktsineerimist, see oli uuringu V59P20 pikendusuuring.
English: At 1 year post vaccination, Menveo continued to be statistically higher than ACWY-PS for serogroups A, W-135 and Y, as measured by percentage of subjects with hSBA≥1:8 and GMTs.
Estonian: Üks aasta pärast vaktsiini manustamist oli Menveo serogruppides A, W-135 ja Y statistiliselt jätkuvalt kõrgem kui ACWY-PS (võttes aluseks hSBA ≥1:8 ja GMT osakaalu).
English: Potassium dihydrogen phosphate
Estonian: Dinaatriumfosfaatdihüdraat
English: The reactogenicity profile and rates of adverse events among subjects aged 56-65 years who received Menveo (N=216), were similar to that observed in Menveo recipient subjects aged 11-55.
Estonian: 56...65 aasta vanuste Menveo saajate (N=216) reaktogeensuse profiil ja kõrvaltoimete määr sarnanesid samadele näitajatele vanusegrupis 11...55 aastat.
English: Overall 3464 subjects aged 2 to10 years were exposed to Menveo in completed clinical trials.
Estonian: Lõpuleviidud kliinilistes uuringutes manustati Menveod kokku 3464 isikule vanuses 2...10 aastat.
English: • Meningococcal group A oligosaccharide
Estonian: • Meningokoki A-grupi oligosahhariid
English: At baseline, the percentage of subjects with hSBA ≥1:8 across the two age strata was 1%-5% for serogroup A, 13%-28% for serogroup C, 42%-64% for serogroup W-135, and 6%-19% for serogroup
Estonian: Alusväärtuse juures oli mõlemas vanusrühmas patsientide protsent, kelle hSBA ≥1:8, A-serogrupi korral 1-5%, C-serogrupi korral 13-28%, W-135 serogrupi korral 42-64% ja Y-serogrupi korral 619%.
English: NAME OF THE MEDICINAL PRODUCT Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine
Estonian: RAVIMPREPARAADI NIMETUS Menveo süstelahuse pulber ja lahus Meningokoki gruppide A, C, W-135 ja Y konjugeeritud vaktsiin
English: • Meningococcal group Y oligosaccharide
Estonian: • Meningokoki Y-grupi oligosahhariid
English: Menveo is a powder and a solution for injection.
Estonian: Menveo on pulber ja süstelahus
English: Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine
Estonian: Menveo süstelahuse pulber ja lahus Meningokoki gruppide A, C, W-135 ja Y konjugeeritud vaktsiin
English: and 6-10 years of age, respectively, had hSBA ≥ 1:8 (GMTs 2.95 and 3.73).
Estonian: Serogrupi A korral oli patsientidest vanuses 2...5 ja 6...10 vastavalt 14%-l ja 22%- hSBA ≥ 1:8 (GMT-d 2,95 ja 3,73).
English: Very common: irritability, malaise, injection site pain, injection site erythema (≤50 mm), injection site induration (≤50 mm)
Estonian: Väga sage: ärrituvus, haiglane enesetunne, valu süstekohas, süstekoha erüteem (≤50 mm), süstekoha induratsioon (≤50 mm)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENA LYOPHILISED CONJUGATE COMPONENT
Estonian: VIAALI ETIKETT MENA LÜOFILISEERITUD KONJUGAAT
English: Intramuscular use
Estonian: Intramuskulaarseks kasutamiseks
English: In study V59P6E1, at one year post vaccination, the percentage of Menveo recipients with hSBA ≥ 1:8 remained significantly higher compared with ACWY-PS recipients for serogroups C, W-135 and Y, and similar between the two study groups for serogroup A. hSBA GMTs for serogroups W-135 and Y were higher among Menveo recipients.
Estonian: Uuringus V59P6E1 oli üks aasta pärast vaktsineerimist C-, W-135- ja Y-serogruppide puhul Menveo patsientide arv, kelle hSBA oli ≥ 1 : 8, märkimisväärselt kõrgem kui ACWY-PS-id saanud patsientide arv.
English: The presence of a minor infection is not a contraindication.
Estonian: Kergekujuline põletik pole vastunäidustus.
English: The contents of the two components (vial and vial) are to be mixed prior to vaccination providing 1 dose of 0.5 ml.
Estonian: Mõlema komponendi (viaali ja viaali) sisud tuleb enne vaktsineerimist kokku segada.
English: To ensure optimal antibody levels against all vaccine serogroups, the primary vaccination schedule with Menveo should be completed one month prior to risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y. Bactericidal antibodies (hSBA≥1:8) were observed in at least 64% of subjects at 1 week post vaccination (see section 5.1 for immunogenicity data per individual serogroups).
Estonian: Antikehade optimaalse taseme kindlustamiseks vaktsiini kõigi serogruppide vastu tuleb Menveo esmane vaktsineerimisplaan lõpetada ühe kuu jooksul enne Neisseria meningitidis'e gruppide A, C,
English: In children (from 2 to 10 years of age), the side effects that were reported during clinical trials are listed below.
Estonian: Kliiniliste uuringute alusel on lastel (vanuses 2 kuni 10 aastat) kõige levinumad allpool loetletud kõrvaltoimed.
English: ACWY-PS for all four serogroups and statistically superior for serogroups A and Y (Table 10).
Estonian: Isikute, kelle hSBA oli ≥ 1:8, osakaal oli samaväärne ACWY-PSga kõigis neljas serogrupis ja statistiliselt suurem serogruppides A ja Y (tabel 10).
English: Very common: headache, nausea, injection site pain, injection site redness (≤ 50 mm), injection site firmness (≤ 50 mm), muscle ache, generally feeling unwell
Estonian: Väga sage: peavalu, iiveldus, süstekoha valu, süstekoha punetus (≤50 mm), süstekoha kõvenemine (≤50 mm), lihaste valulikkus, üldine halb enesetunne Sage: lööve, süstekoha punetus (>50 mm), süstekoha kõvenemine (>50 mm), liigeste valulikkus, palavik ≥ 38°C, külmavärinad
English: Common: injection site erythema (>50 mm), injection site induration (>50 mm), fever ≥38°C, chills Uncommon: injection site pruritus
Estonian: Sage: süstekoha punetus (>50 mm), süstekoha kõvastumine (>50 mm), palavik ≥38°C, külmavärinad Aeg-ajalt: süstekoha sügelus
English: Meningococcal group A oligosaccharides 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7-33.3 micrograms
Estonian: 10 mikrogrammi Konjugeeritud Corynebacterium diphtheriae CRM197 proteiiniga 16,7 kuni 33,3 mikrogrammi
English: There was evidence of some suppression of antibody response to two of the three pertussis antigens.
Estonian: Kahel kolmest läkaköha antigeenist tuvastati mõningane immuunvastuse supressioon.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Estonian: RAVIMI VÄLJASTAMISTINGIMUSED Retseptiravim.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menveo solution for injection
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Menveo süstelahus
English: GlaxoSmithKline GmbH & Co. KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
Estonian: KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
English: Meningococcal group W-135 oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3-8.3 micrograms
Estonian: 5 mikrogrammi meningokoki W-135-grupi oligosahhariide, segatud 3,3 kuni 8,3 mikrogrammi Corynebacterium diphtheriae CRM197 proteiiniga
English: Musculoskeletal and connective tissue disorders:
Estonian: Lihas-skeleti ja sidekoe kahjustused
English: CI) A N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
Estonian: A N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
English: Meningococcal group C oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1-12.5 micrograms
Estonian: 5 mikrogrammi Konjugeeritud Corynebacterium diphtheriae CRM197 proteiiniga 7,1 kuni 12,5 mikrogrammi
English: Non-clinical data reveal no special hazard for humans based on conventional repeated-dose and reproductive and developmental toxicity studies.
Estonian: Korduvtoksilisuse, reproduktsiooni- ja arengutoksilisuse mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: In adolescents (from 11 years of age) and adults, the most common side effects that were reported during clinical trials are listed below.
Estonian: Aeg-ajalt (võib tekkida kuni 1 kasutajal 100-st): süstekoha sügelus Kliiniliste uuringute alusel on noorukitel (alates vanusest 11 aastat) ja täiskasvanutel kõige levinumad allpool loetletud kõrvaltoimed.
English: The vaccine is usually given into the upper arm muscle (deltoid) for children (from 2 years of age), adolescents and adults.
Estonian: Lastel (alates vanusest 2 aastat), täiskasvanutel ja noorukitel süstitakse vaktsiin tavaliselt käsivarre ülaossa (deltalihasesse).
English: Meningococcal group Y oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6-10.0 micrograms.
Estonian: 5 mikrogrammi Konjugeeritud Corynebacterium diphtheriae CRM197 proteiiniga 5,6 kuni 10,0 mikrogrammi
English: Common: injection site erythema (>50mm), injection site induration (>50mm), chills, fever ≥38oC
Estonian: Sage: süstekoha erüteem (>50 mm), süstekoha induratsioon (>50 mm), külmavärinad, palavik ≥38°C Aeg-ajalt: süstekoha sügelus
English: Percentages of subjects with hSBA≥1:8
Estonian: Isikute protsent, kelle hSBA ≥ 1:8
English: General disorders and administration site conditions Not known: injection site cellulitis, injection site swelling, including extensive swelling of the injected limb
Estonian: Teadmata: tselluliit või turse süstekohas, sh süsti saanud jäseme ulatuslik turse Võimalikest kõrvaltoimetest teavitamine
English: Timepoint
Estonian: Ajapunkt
English: and Y, with the percentages of subjects with hSBA ≥ 1:8 being 32% and 56% against serogroup C in subjects 2-5 and 6-10 years of age, respectively, 74% and 80% against serogroup W-135, and 48% and 53% against serogroup Y. GMTs were respectively 6.5 and 12 for serogroup C, 19 and 26 for serogroup W-135, and 8.13 and 10 for serogroup Y. For serogroup A, 14% and 22% of subjects 2-5
Estonian: Patsiente vanuses 2...5 ja 6...10 aastat, kelle hSBA ≥ 1:8, oli serogrupi C korral vastavalt 32% ja 56%, serogrupi W-135 korral vastavalt 74% ja 80% ning serogrupi Y korral vastavalt 48% ja 53%.
English: It must not be administered intravascularly, subcutaneously or intradermally.
Estonian: Seda ei tohi manustada veresoonesisese, nahaaluse ega nahasisese süstena.
English: (≤50 mm), malaise
Estonian: süstekoha kõvenemine (>50 mm)
English: A booster dose of Menveo was administered 5 years after primary vaccination with Menveo or ACWY-PS. At 7 days after the booster dose, 98%-100% of subjects who previously received Menveo and 73%-84% of subjects who previously received ACWY-PS achieved hSBA ≥1:8 against serogroups A, C, W-135 and Y. At one month post vaccination, the percentages of subjects with hSBA≥1:8 were 98%-100% and 84%-96%, respectively.
Estonian: 7. päeval pärast kordusannust oli 98%...100% varem Menveot saanud patsientide ja 73%...84% varem ACWY-PS-i saanud patsientide hSBA ≥1 : 8 A-, C-, W-135- ja Y-serogruppide suhtes.
English: In 5 years post vaccination, the percentage of Menveo recipients with hSBA ≥ 1:8 remained significantly higher compared with ACWY-PS recipients for serogroups C and Y. Higher hSBA GMTs were observed for serogroups W-135 and Y (Table 7).
Estonian: W-135- ja Y-serogruppide puhul täheldati kõrgemaid hSBA GMT-de väärtusi (tabel 7).
English: Common (may affect up to 1 in 10 people): change in eating habits, nausea, vomiting, diarrhea, rash, muscle ache, joint ache, chills, fever ≥38oC, injection site redness (>50mm) and injection site firmness (>50mm)
Estonian: Sage (võib tekkida kuni 1 inimesel 10-st): söömistavade muutus, iiveldus, oksendamine, diarröa,
English: At 7 days post vaccination, 64% of subjects achieved hSBA ≥1:8 against serogroup A and 88% through 90% of subjects had bactericidal antibodies against serogroups C, W-135 and Y. At one month post vaccination, 92% through 98% of subjects had hSBA ≥1:8 against serogroups A, C, W-135 and Y. A robust immune response as measured by hSBA GMTs against all serogroups was also observed at 7 days (GMTs 34 through 70) and 28 days (GMTs 79 through 127) after a single dose vaccination.
Estonian: 7. päeval pärast vaktsineerimist oli 64% patsientide hSBA ≥ 1 : 8 A-serogrupi suhtes ja 88%...90% patsientidel olid bakteritsiidsed antikehad C-, W-135- ja Y-serogruppide vastu.
English: Persistence of immune response and booster response in adolescents
Estonian: Immuunvastuse ja kordusannuse vastuse püsivus lastel vanuses 2...10 aastat
English: Very common: injection site pain, injection site erythema (≤50 mm), injection site induration
Estonian: Väga sage: süstekoha valu, süstekoha punetus (≤50 mm), süstekoha kõvastumine (≤50 mm),
English: Y. At 1 month post last vaccination, the percentages of subjects with hSBA ≥1:8 in the 2-dose group and in the single dose group across the two age strata were: 90%-95% vs 76%-80% for serogroup A, 98%-99% vs 76%-87% for serogroup C, 99% vs 93%-96% for serogroup W-135, and 96% vs 65%69% for serogroup Y. GMTs were higher in the 2-dose group than the single dose group at 1 month after vaccination in both age strata; however, this difference was less pronounced in the older age stratum.
Estonian: C-serogrupi korral 98-99% vs. 76%-87%, W-135-serogrupi korral 99% vs. 93-96% ja Y-serogrupi korral 96% vs. 65-69%.
English: GlaxoSmithKline S.p.A. Tel: +39 (0)45 9218 111
Estonian: Tel: +39 (0)45 9218 111
English: Immune system disorders
Estonian: Seedetrakti häired
English: Serogr oup
Estonian: Serogr upp Ajapunkt
English: • The Committee considered Protelos and Osseor (strontium ranelate) in the procedure under Article 20 of Regulation (EC) No 726/2004, initiated by the European Commission.
Estonian: Euroopa Komisjoni algatas 2013. aasta mais ravimite Protelos/Osseor määruse (EÜ) nr 726/2004 artikli 20 kohase läbivaatamise.
English: Overall conclusion
Estonian: Lisateave menetluse kohta
English: Background information
Estonian: Teave patsientidele
English: The relative risk reduction of proximal femur and hip area fractures with strontium ranelate over 3 years (FAS population from TROPOS) was not statistically significant compared with placebo: 15% (RR=0.85, 95% CI [0.61; 1.19], p=0.333) and 21% (RR=0.79, 95% CI [0.59; 1.06], p=0.112), respectively.
Estonian: Nende tulemuste põhjal suurenes Protelose/Osseori kasutamisel platseeboga võrreldes südamelihaseinfarkti risk (vastavalt 1,7% ja 1,1%), suhteline risk 1,6 (95% usaldusvahemik, 1,07 kuni 2,38), ja venoossete trombembooliate juhtumite risk: vastavalt 1,9% ja 1,3%, suhteline risk 1,5 (95% usaldusvahemik, 1,04 kuni 2,19).
English: In view of the data provided and other treatment alternatives available, some experts, in particular the experts in osteoporosis were of the opinion that a patient population could benefit from the product.
Estonian: Protelose/Osseori kasutamise otsustamisel arvestas inimravimite komitee ravimiohutuse riskihindamiskomitee analüüsi ravimi kasulikkuse ja riskide kohta ning osteoporoosispetsialistide nõuandeid, et teatud patsientidele võib ravim kasulik olla.
English: In order to assess the impact of the restrictions introduced in the product information, namely the restriction to patients with severe osteoporosis and patients without the contraindications (current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism; temporary or permanent immobilisation due to e.g. post-surgical recovery or prolonged bed rest; established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease, or uncontrolled hypertension), post-hoc subgroup analyses of the existing clinical trial data were performed.
Estonian: Olemasolevate andmete põhjal ei ole kardiovaskulaarne risk suurem patsientidel, kellel ei ole diagnoosiga kinnitatud esinev või varem esinenud südame isheemiatõbi, perifeersete arterite haigus, tserebrovaskulaarne haigus või ravimata hüpertensioon.
English: • The Committee concluded, in view of the available data, that given the number of identified serious risks, for which there are considerable doubts that they can be adequately mitigated during long-term treatment, in the context of the modest benefit shown in terms of fracture prevention, the benefit-risk balance of Protelos and Osseor is not favourable.
Estonian: Komitee jõudis järeldusele, et arvestades murdude ennetamise kasulikku mõju suure luumurruriskiga patsientidel, peab Protelos/Osseor olema jätkuvalt saadaval
English: Overall summary of the scientific evaluation of Protelos/Osseor by the PRAC
Estonian: „Inimravimite komitee nõustus ravimiohutuse riskihindamiskomitee üldise hinnanguga Protelose/Osseori riskide suhtes.
English: Strontium ranelate has a different mechanism of action from other available products; this might be a valuable alternative, particularly in long-term treatment of osteoporosis and for patients for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.
Estonian: • Protelost/Osseori tohib kasutada ainult raske osteoporoosiga meeste ja menopausijärgses eas naiste raviks, kellel on suur luumurrurisk ja keda ei saa vastunäidustuste või talumatuse tõttu ravida teiste osteoporoosi raviks heaks kiidetud ravimitega.
English: However the CHMP took the view that assessment of cardiovascular risk is a primary task for practising physicians, mainly relying on accessible information (such as family and patient history, smoking status, body mass index, waist circumference, blood pressure) and commonly investigated laboratory values (such as blood glucose and lipids).
Estonian: Lisaks peab arst neid patsiente regulaarselt hindama ja ravi tuleb peatada, kui patsiendil tekivad südame- või veresoonkonna probleemid, nagu ravimata hüpertensioon (kõrge vererõhk) või angiin.
English: The CHMP, having considered the PRAC recommendation dated January 2014 and the totality of the information provided by the MAH, is of the opinion that the benefit-risk balance of strontium ranelate remains positive in the restricted population, taking into account the agreed risk minimisation measures, including changes to the product information and additional pharmacovigilance activities.
Estonian: „Ravimiohutuse riskihindamiskomitee on kogu menetluse käigus inimravimite komiteega tihedat koostööd teinud ja kuigi tunnistame, et kahe komitee soovitused on erinevad, oleme üksmeelel ravimite kasulikkuse ja riski profiili suhtes ning mõlemad komiteed peavad oluliseks kardiovaskulaarse riski tõhusat jälgimist,” ütles ravimiohutuse riskihindamiskomitee esinaine June Raine.
English: Scientific conclusions
Estonian: Teave tervishoiutöötajatele
English: The risk minimisation measures included reducing the target population by excluding patients with high risk for ischemic cardiac disorders, and restricting the indication to patients with severe osteoporosis, who are most likely to benefit from treatment.
Estonian: Inimravimite komitee otsustas, et Protelost/Osseori võtvate patsientide kardiovaskulaarsete haiguste riski saab kontrolli all hoida, kui piirata ravimite kasutust patsientidega, kellel ei ole varem esinenud südame- ega veresoonkonna probleeme ja kes ei saa kasutada teisi osteoporoosi raviks heaks kiidetud ravimeid.
English: In order to address the concern that cardiovascular risk may increase considerably over time in the predominantly elderly target population, the MAH proposed regular assessment of the patients' cardiovascular risk.
Estonian: Patsiendi kardiovaskulaarse haiguse tekke riski tuleb hinnata enne ravi alustamist ja seejärel regulaarselt, tavaliselt iga 6 kuni 12 kuu järel.
English: The PRAC, having considered the matter, recommended the suspension of the marketing authorisation for Protelos and Osseor.
Estonian: EMA inimravimite komitee lõplikud soovitused anti pärast ravimiohutuse riskihindamiskomitee algset soovitust ravimi müügiluba kardiovaskulaarse riski tõttu peatada.
English: This is expected to better characterise the risk in the restricted population and also to assess the effectiveness of the risk minimisation measures.
Estonian: Lisaks peab ettevõte korraldama lisauuringuid, et näidata uute meetmete tõhusust.
English: • The CHMP agreed that there are a number of risks associated to strontium ranelate, including an increased risk of serious cardiac disorders observed in the postmenopausal population.
Estonian: • Enne ravi alustamist hindab arst südamehaiguste ja kõrge vererõhu riski ning kontrollib seda riski ravi jooksul regulaarsete ajavahemike järel.
English: When fracture data from randomised, placebo-controlled studies in postmenopausal women were reviewed, the magnitude of the benefit of fracture prevention was found to be modest, particularly regarding the most serious types of fractures.
Estonian: Lõpliku otsuse tegemisel märkis inimravimite komitee, et uuringute andmed on näidanud kasulikku mõju murdude ennetamisel, sealhulgas suure luumurruriskiga patsientidel.
English: • Given the totality of the risks associated to strontium ranelate, the CHMP considered it appropriate that use of strontium ranelate be restricted to patients for whom treatment with other medicinal products is not possible due to, for example, contraindications or intolerance.
Estonian: Euroopa Ravimiamet lõpetas Protelose/Osseori läbivaatamise ja soovitas ravimi kasutamist täiendavalt piirata patsientidega, keda ei saa ravida teiste osteoporoosi raviks heaks kiidetud ravimitega.
English: Strontium ranelate is associated with a number of serious adverse events including serious cardiac disorders, thromboembolic events, serious skin reactions, disturbances in consciousness, seizures, hepatitis and blood cytopenic disorders.
Estonian: • Protelost/Osseori ei tohi võtta, kui teil on või on olnud südame- või veresoonkonna probleeme, nagu insult, südamelihaseinfarkt või arteriverevoolu häired.
English: The MAH has provided a study outline for a post-authorisation safety study using the EU-ADR Alliance databases.
Estonian: Lisateave ravimiohutuse riskihindamiskomitee soovituse kohta ja läbivaatamise taustteave on Euroopa Ravimiameti veebisaidil.
English: The CHMP agreed with the conclusions of the PRAC that the use of strontium ranelate in a broad osteoporosis population (postmenopausal population) is associated with a number of serious risks; namely serious cardiac disorders (including myocardial infarction), thromboembolic events (including VTE), serious skin reactions (including DRESS syndrome, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis), disturbances in consciousness, seizures, hepatitis and blood cytopenic disorders.
Estonian: Ravimitele Protelos/Osseor (strontsiumranelaat) on Euroopa Liidus antud müügiluba raske osteoporoosi (haigus, mis muudab luud hapraks) raviks suure luumurruriskiga menopausijärgses eas naistel, et vähendada lülisamba või puusaliigese murru riski.
English: Benefits of strontium ranelate in the treatment of osteoporosis
Estonian: Seda kasutatakse ka raske osteoporoosi raviks suure luumurruriskiga meestel.
English: • The Committee considered that the exclusion of patients with contraindications relating to cardiovascular and thromboembolic risks impacted on the statistical significance of the observed increased risks.
Estonian: • Arstide otsus Protelost/Osseori määrata peab põhinema iga patsiendi võimalike riskide hindamisel.
English: • The CHMP requested that the MAH shall conduct a post-authorisation safety study to assess whether, within the limited patient population which is expected to be exposed to strontium ranelate, there is compliance with the restrictions introduced, and to collect further information on the risks of the medicinal product and on the effectiveness of the risk minimisation measures.
Estonian: „Ravimiohutuse riskihindamiskomitee jätkab Protelose/Osseori ohutuse jälgimist ja riski minimeerimise meetmete tõhusust pikaajalise kasutuse korral.”