natgillin/translations-raw huggingface dataset:
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.
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.
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).
W-135- ja Y-serogruppide puhul täheldati kõrgemaid hSBA GMT-de väärtusi (tabel 7).
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)
Sage (võib tekkida kuni 1 inimesel 10-st): söömistavade muutus, iiveldus, oksendamine, diarröa,
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.
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.
Persistence of immune response and booster response in adolescents
Immuunvastuse ja kordusannuse vastuse püsivus lastel vanuses 2...10 aastat
Very common: injection site pain, injection site erythema (≤50 mm), injection site induration
Väga sage: süstekoha valu, süstekoha punetus (≤50 mm), süstekoha kõvastumine (≤50 mm),
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.
C-serogrupi korral 98-99% vs. 76%-87%, W-135-serogrupi korral 99% vs. 93-96% ja Y-serogrupi korral 96% vs. 65-69%.
GlaxoSmithKline S.p.A. Tel: +39 (0)45 9218 111
Tel: +39 (0)45 9218 111
Immune system disorders
Seedetrakti häired
Serogr oup
Serogr upp Ajapunkt
• 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.
Euroopa Komisjoni algatas 2013. aasta mais ravimite Protelos/Osseor määruse (EÜ) nr 726/2004 artikli 20 kohase läbivaatamise.
Overall conclusion
Lisateave menetluse kohta
Background information
Teave patsientidele
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.
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).
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.
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.
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.
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.
• 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.
Komitee jõudis järeldusele, et arvestades murdude ennetamise kasulikku mõju suure luumurruriskiga patsientidel, peab Protelos/Osseor olema jätkuvalt saadaval
Overall summary of the scientific evaluation of Protelos/Osseor by the PRAC
„Inimravimite komitee nõustus ravimiohutuse riskihindamiskomitee üldise hinnanguga Protelose/Osseori riskide suhtes.
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.
• 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.
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).
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.
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.
„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.
Scientific conclusions
Teave tervishoiutöötajatele
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.
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.
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.
Patsiendi kardiovaskulaarse haiguse tekke riski tuleb hinnata enne ravi alustamist ja seejärel regulaarselt, tavaliselt iga 6 kuni 12 kuu järel.
The PRAC, having considered the matter, recommended the suspension of the marketing authorisation for Protelos and Osseor.
EMA inimravimite komitee lõplikud soovitused anti pärast ravimiohutuse riskihindamiskomitee algset soovitust ravimi müügiluba kardiovaskulaarse riski tõttu peatada.
This is expected to better characterise the risk in the restricted population and also to assess the effectiveness of the risk minimisation measures.
Lisaks peab ettevõte korraldama lisauuringuid, et näidata uute meetmete tõhusust.
• 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.
• Enne ravi alustamist hindab arst südamehaiguste ja kõrge vererõhu riski ning kontrollib seda riski ravi jooksul regulaarsete ajavahemike järel.
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.
Lõpliku otsuse tegemisel märkis inimravimite komitee, et uuringute andmed on näidanud kasulikku mõju murdude ennetamisel, sealhulgas suure luumurruriskiga patsientidel.
• 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.
Euroopa Ravimiamet lõpetas Protelose/Osseori läbivaatamise ja soovitas ravimi kasutamist täiendavalt piirata patsientidega, keda ei saa ravida teiste osteoporoosi raviks heaks kiidetud ravimitega.
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.
• Protelost/Osseori ei tohi võtta, kui teil on või on olnud südame- või veresoonkonna probleeme, nagu insult, südamelihaseinfarkt või arteriverevoolu häired.
The MAH has provided a study outline for a post-authorisation safety study using the EU-ADR Alliance databases.
Lisateave ravimiohutuse riskihindamiskomitee soovituse kohta ja läbivaatamise taustteave on Euroopa Ravimiameti veebisaidil.
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.
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.
Benefits of strontium ranelate in the treatment of osteoporosis
Seda kasutatakse ka raske osteoporoosi raviks suure luumurruriskiga meestel.
• 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.
• Arstide otsus Protelost/Osseori määrata peab põhinema iga patsiendi võimalike riskide hindamisel.
• 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.
„Ravimiohutuse riskihindamiskomitee jätkab Protelose/Osseori ohutuse jälgimist ja riski minimeerimise meetmete tõhusust pikaajalise kasutuse korral.”
However, the retrospective subgroup analyses performed by the MAH support the conclusion that the risks for vascular complications seemed to be reduced to a neutral level by the exclusion of patients with identified increased cardiovascular risk while anti-fracture efficacy seems to be preserved, even in the subset of patients with severe osteoporosis.
„Inimravimite komitee jõudis aga järeldusele, et patsientidel, kelle puhul ei ole muu ravi võimalik, vähendab regulaarne jälgimine kardiovaskulaarsete haiguste välistamiseks ravimiohutuse riskihindamiskomitee tuvastatud riskide esinemist piisavalt, nii et need patsiendid saavad jätkuvalt seda ravimit võtta.”
Strontium ranelate, the active substance of Protelos/Osseor, is composed of two atoms of stable strontium and one molecule of ranelic acid.
• Ravi Protelose/Osseoriga tuleb peatada, kui patsiendil tekib südame isheemiatõbi, perifeersete arterite haigus või ravimata hüpertensioon.
While it is agreed that the pooled postmenopausal dataset is relevant for safety evaluation, the CHMP considered that the anti-fracture efficacy should be analysed based on data from the phase 3 studies TROPOS and SOTI conducted over 3 years in a population at high risk of fractures, with fractures defined as primary endpoint.
Euroopa Ravimiameti lõplik soovitus Protelose/Osseori kasutamise kohta põhineb randomiseeritud uuringute, kus osales ligikaudu 7500 menopausijärgses eas osteoporoosiga naist, koondandmete analüüsil.
Grounds for PRAC recommendation
Lisateave ravimi kohta
The CHMP therefore recommended the variation of the marketing authorisations for Protelos and Osseor.
Ravimite Protelos/Osseor müügiluba jääb kehtima, aga lisapiirangutega
Experts also specified that strontium ranelate should be used only in severe osteoporosis with significant fragility fracture such as hip and not “trivial” ones such as metacarpal (which was given as an example).
• Protelost/Osseori määratakse luumurdude ennetamiseks ainult raske osteoporoosiga meestel ja menopausijärgses eas naistel, kellel on suur luumurrurisk ja keda ei saa teiste osteoporoosi raviks heaks kiidetud ravimitega ravida.
The postmenopausal osteoporotic (PMO) population for strontium ranelate comprises data from 7 randomised studies: 2 phase II studies CL2-004 (Meunier, 2002; NP07869) and CL2-005 (Reginster 2002; NP08511) and 5 phase III studies CL3-009 (Meunier, 2004; NP08338/NP22819), CL3-010 (Reginster 2005; NP08340/NP22824), CL3-013 (Hwang 2008; NP22514), CL3-015 (Liu 2009; NP25026), CL3-017 (NP24357).
Tel. +44 (0)20 7418 8427 E-post: press@ema.europa.eu
It blocks the proteasome, which is a system within the cells that breaks down proteins when they are no longer needed.
See blokeerib proteasoomi ehk rakusisese süsteemi, mis lagundab valke, kui neid enam ei vajata.
Further information on Bortezomib Fresenius Kabi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
Lisateave Bortezomib Fresenius Kabi kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/bortezomib-fresenius-kabi.
The recommended starting dose depends on the patient's height and weight.
Soovitatav algannus sõltub patsiendi pikkusest ja kehamassist.
For more information on generic medicines, see the question-andanswer document here.
Lisateave geneeriliste ravimite kohta on teabedokumendis siin.
• adults whose disease is getting worse after at least one other treatment and who have already had, or cannot undergo, a blood stem-cell transplant.
• Täiskasvanud, kelle haigus süveneb pärast vähemalt üht muud raviskeemi ja kellele on vereloome tüvirakke juba siiratud või ei saa siirata.
Patients with moderately or severely impaired liver function should be treated with lower doses.
Mõõduka või raske maksatalitlushäirega patsientide annus peab olema väiksem.
What measures are being taken to ensure the safe and effective use of Bortezomib Fresenius Kabi?
Mis meetmed võetakse, et tagada Bortezomib Fresenius Kabi ohutu ja efektiivne kasutamine?
The European Medicines Agency concluded that, in accordance with EU requirements, Bortezomib Fresenius Kabi has been shown to be comparable to Velcade.
Euroopa Ravimiamet järeldas, et vastavalt ELi nõuetele on tõendatud Bortezomib Fresenius Kabi võrreldavus ravimiga Velcade.
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Velcade, and do not need to be repeated for Bortezomib Fresenius Kabi.
Võrdlusravimiga Velcade on juba tehtud toimeaine heakskiidetud kasutamisviisi kasulikkuse ja riski uuringud ja neid ei ole vaja ravimiga Bortezomib Fresenius Kabi korrata.
Doses of Bortezomib Fresenius Kabi are given intermittently, with rest periods in between doses, in treatment cycles of three to six weeks depending on whether Bortezomib Fresenius Kabi is given alone or in combination with other medicines.
Ravimit Bortezomib Fresenius Kabi manustatakse ravikuuridena, jättes annuste vahele puhkeperioodi, nii et ravikuurid kestavad 3-6 nädalat sõltuvalt sellest, kas Bortezomib Fresenius Kabit kasutatakse ainuravimina või koos muude ravimitega.
Bortezomib Fresenius Kabi (bortezomib)
Bortezomib Fresenius Kabi (bortesomiib)
This means that Bortezomib Fresenius Kabi contains the same active substance, bortezomib, and works in the same way as a ‘reference medicine' already authorised in the EU called Velcade.
See tähendab, et Bortezomib Fresenius Kabi sisaldab sama toimeainet, bortesomiibi, ja toimib samamoodi nagu võrdlusravim Velcade, millel juba on ELis müügiluba.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bortezomib Fresenius Kabi have also been included in the summary of product characteristics and the package leaflet.
Ravimi Bortezomib Fresenius Kabi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
Because Bortezomib Fresenius Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Et Bortezomib Fresenius Kabi on geneeriline ravim, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
Therefore, the Agency's view was that, as for Velcade, the benefits of Bortezomib Fresenius Kabi outweigh the identified risks and it can be authorised for use in the EU.
Seetõttu on amet arvamusel, et nagu ka Velcade korral, ületab Bortezomib Fresenius Kabi kasulikkus sellega kaasnevad riskid ja seda võib kasutada ELis.
The company that markets Bortezomib Fresenius Kabi will ensure that healthcare professionals receive educational material explaining how to calculate the dose and how to prepare and administer the medicine.
Bortezomib Fresenius Kabi turustaja annab tervishoiutöötajatele teabematerjalid, milles selgitatakse, kuidas arvutada annust ning ravimit ette valmistada ja manustada.
Side effects reported with Bortezomib Fresenius Kabi are carefully evaluated and any necessary action taken to protect patients.
Ravimi Bortezomib Fresenius Kabi kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
For more information about using Bortezomib Fresenius Kabi, see the package leaflet or contact your doctor or pharmacist.
Lisateavet ravimi Bortezomib Fresenius Kabi kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
Why is Bortezomib Fresenius Kabi authorised in the EU?
Miks Bortezomib Fresenius Kabi ELis heaks kiideti?
As for every medicine, the company provided studies on the quality of Bortezomib Fresenius Kabi.
Nagu iga ravimi korral, esitas ettevõte ravimi Bortezomib Fresenius Kabi kvaliteedi uuringud.
When given into a vein, the solution is given as a three- to five-second injection through a catheter (a thin sterile tube).
Veeni süstimisel manustatakse lahus süstena kateetri (peene steriilse vooliku) kaudu 3-5 sekundi jooksul.
Bortezomib Fresenius Kabi is a ‘generic medicine'.
Bortezomib Fresenius Kabi on geneeriline ravim.
Bortezomib Fresenius Kabi is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation.
Ravimit Bortezomib Fresenius Kabi kasutatakse ka teist tüüpi verevähi, mantelrakulise lümfoomi raviks varem ravimata täiskasvanutel, kellele ei saa siirata vereloome tüvirakke.
When injected under the skin, it is given in the thigh or abdomen (belly).
Kui ravimit süstitakse naha alla, tehakse süst reide või kõhupiirkonda.
What is Bortezomib Fresenius Kabi and what is it used for?
Mis on Bortezomib Fresenius Kabi ja milleks seda kasutatakse?
The medicine can only be obtained with a prescription and treatment should only be started and given under the supervision of a doctor who has experience in the use of cancer medicines.
Bortezomib Fresenius Kabi on retseptiravim ning ravi peab algama ja toimuma vähiravimite kasutamises kogenud arsti järelevalve all.
As for all medicines, data on the use of Bortezomib Fresenius Kabi are continuously monitored.
Nagu kõigi ravimite puhul, tehakse ravimi Bortezomib Fresenius Kabi kasutamise kohta pidevat järelevalvet.
Bortezomib Fresenius Kabi is a medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Bortezomib Fresenius Kabi on ravim, mida kasutatakse hulgimüeloomi (teatud verevähk) raviks järgmistel patsiendirühmadel.
Other information about Bortezomib Fresenius Kabi
Muu teave Bortezomib Fresenius Kabi kohta
Fresenius Kabi is only given by injection into a vein or under the skin.
Ravimit Bortezomib Fresenius Kabi manustatakse üksnes süstena veeni või naha alla.
There was no need for ‘bioequivalence' studies to investigate whether Bortezomib Fresenius Kabi is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Bioekvivalentsust, st kas Bortezomib Fresenius Kabi imendub organismis samamoodi kui võrdlusravim, et saavutada toimeaine sarnane sisaldus veres, ei olnud vaja uurida.
This is because when Bortezomib Fresenius Kabi is given by injection into a vein the active substance is delivered straight into the bloodstream.
Seda ei olnud vaja, sest kui ravimit Bortezomib Fresenius Kabi manustatakse süstena veeni, satub toimeaine otse vereringesse.
For mantle cell lymphoma, Bortezomib Fresenius Kabi is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Mantelrakulise lümfoomi ravis kasutatakse ravimit Bortezomib Fresenius Kabi koos rituksimaabi, tsüklofosfamiidi, doksorubitsiini ja prednisooniga.
Bortezomib Fresenius Kabi is available in vials (3.5 mg) as a powder to be made up into a solution for injection.
Ravimit Bortezomib Fresenius Kabi turustatakse viaalides (3,5 mg) süstelahuse pulbrina.
In these patients, Bortezomib Fresenius Kabi is used in combination with melphalan and prednisone;
Ravimit Bortezomib Fresenius Kabi kasutatakse neil patsientidel koos melfalaani ja prednisooniga.
In this group of patients, Bortezomib Fresenius Kabi is used in combination with dexamethasone, or with dexamethasone plus thalidomide;
Selles patsiendirühmas kasutatakse ravimit Bortezomib Fresenius Kabi koos deksametasooniga või koos deksametasooni ja talidomiidiga.