FrancophonIA/ELRC3.0 huggingface dataset:
English: General disorders and administration site conditions Not known: injection site cellulitis, injection site swelling, including extensive swelling of the injected limb
Slovak: Neznáme: celulitída v mieste podania injekcie, opuch v mieste podania injekcie vrátane rozsiahleho opuchu končatiny, do ktorej bola podaná injekcia
English: Each dose of Menveo is supplied as a: - 1 Vial containing the MenA Lyophilised Conjugate Component as a white to off-white powder - 1 Vial containing the MenCWY Liquid Conjugate Component as clear solution - Pack size of one dose (2 vials) or five doses (10 vials).
Slovak: Každá dávka očkovacej látky Menveo sa dodáva ako: - 1 liekovka obsahujúca komponent lyofilizovaného konjugátu MenA vo forme bieleho až šedobieleho prášku,
English: Menveo Menveo ACWY-P S
Slovak: Menveo Menveo ACWY-P
English: The immune response observed in the children 2-10 years of age was very similar to those observed in the V59P8 study shown above: immune response to Menveo at 1 month post vaccination, as measured by percentage of subjects with seroresponse, hSBA≥1:8 and GMTs, was non-inferior to ACWY-PS.
Slovak: Imunitná odpoveď pozorovaná u detí vo veku 2 - 10 rokov bola veľmi podobná ako odpoveď pozorovaná v štúdii V59P8 spomínanej vyššie: imunitná odpoveď na očkovaciu látku Menveo 1 mesiac po očkovaní,
English: Antibody responses to Menveo and the diphtheria, tetanus or HPV vaccine components were not negatively affected by co-administration.
Slovak: tetanu alebo HPV neboli ovplyvnené spoločným podaním.
English: Table 9: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 19-55 years
Slovak: Tabuľka 9: Baktericídna protilátková odpoveďv sére po podaní očkovacej látky Menveo jeden mesiac po očkovaní u osôb vo veku 19 - 55 rokov
English: In the 11-18 year old population of the pivotal study, V59P13, the immunogenicity of a single dose of Menveo one month post vaccination is compared with the ACWY-D. Immunogenicity results at one month after Menveo are summarized below in Table 4.
Slovak: V populácii osôb pivotnej štúdie, V59P13, vo veku od 11 - 18 rokov sa porovnávala imunogenita jednej dávky očkovacej látky Menveo jeden mesiac po očkovaní s imunogenitou ACWY-D.
English: In the subset of subjects aged 19-55 years who were seronegative at baseline, the proportion of subjects who achieved a hSBA ≥ 1:8 after a dose of Menveo were as follows: serogroup A 67% (582/875); serogroup C 71% (401/563); serogroup W135 82% (131/160); serogroup Y 66% (173/263).
Slovak: A 67 % (582/875); séroskupina C 71 % (401/563); séroskupina W-135 82 % (131/160); séroskupina Y 66 % (173/263).
English: Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine
Slovak: Menveo prášok a roztok na injekčný roztok Konjugovaná očkovacia látka proti meningokokom skupín A, C, W-135 a Y
English: A significant increase in the hSBA GMTs against all four serogroups was also observed at 7 and 28 days after the booster dose (Table 8).
Slovak: Silnejšia imunitná odpoveď na základe merania hodnôt hSBA GMT proti všetkým séroskupinám bola pozorovaná aj na 7. deň (GMT 34 až 70) a 28. deň
English: Conjugated to Corynebacterium diphtheriae CRM197 protein
Slovak: Konjugovaný na proteín CRM197
English: GlaxoSmithKline GmbH & Co. KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
Slovak: KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
English: Table 5: Immunogenicity of one dose of Menveo or ACWY-PS in adolescents, measured at one month post vaccination
Slovak: Tabuľka 5: Imunogenita jednej dávky očkovacej látky Menveo alebo ACWY-PS u dospievajúcich meraná jeden mesiac po očkovaní
English: Table 1: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 2-5 years and 6-10 years
Slovak: Tabuľka 1: Baktericídna protilátková odpoveď v sére po podaní očkovacej látky Menveo jeden mesiac po očkovaní u osôb vo veku 2-5 rokov a 6-10 rokov
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovak: Únie (zoznam EURD)
English: Menveo must be prepared for administration by reconstituting the powder with the solution.
Slovak: Očkovacia látka Menveo sa musí pripraviť na podanie rekonštitúciou prášku s roztokom.
English: Table 4: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 11-18 years
Slovak: Tabuľka 4: Baktericídna protilátková odpoveď v sére po podaní očkovacej látky Menveo jeden mesiac po očkovaní u osôb vo veku 11 - 18 rokov
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.
Slovak: Menveo, jeden rok po očkovaní signifikantne vyššie v porovnaní s osobami, ktoré dostali očkovaciu látku ACWY-PS pri séroskupinách C, W-135 a Y a podobné medzi dvomi skúšanými skupinami pri séroskupine A. Hodnoty hSBA GMT pri séroskupinách W-135 a Y boli vyššie medzi osobami, ktoré dostali očkovaciu látku Menveo.
English: Not known (cannot be estimated from the available data) Adverse reactions from clinical trials
Slovak: Neznáme (z dostupných údajov)
English: Menveo is a powder and a solution for injection.
Slovak: Menveo je prášok a roztok na injekčný roztok.
English: At 1 month post-first vaccination, the percentages of subjects with hSBA ≥ 1:8 were consistently higher in the Menveo group for all four serogroups (63% vs 39%, 46% vs 39%, 78% vs 59%, and 65% vs 57% for Menveo as compared to ACWY-PS for serogroups A, C, W-135, and Y, respectively).
Slovak: % oproti 39 %, 46 % oproti 39 %, 78 % oproti 59 % a 65 % oproti 57 % pre Menveo v porovnaní s očkovacou látkou ACWY-PS pre séroskupiny A, C, W-135 a Y).
English: United Kingdom GlaxoSmithKline UK Tel: +44 (0)800 221 441 customercontactuk@gsk.com
Slovak: + 44 (0)800 221 441 customercontactuk@gsk.com
English: Serogroup hSBA ≥1:8
Slovak: Séroskupina hSBA ≥
English: The percentages of subjects with hSBA ≥ 1:8 remained constant against serogroups C, W-135, and Y from 21 months to 5 years postvaccination in the Menveo group and decreased slightly over time against serogroup A (Table 6).
Slovak: 1:8 proti séroskupinám C, W-135 a Y v skupine s očkovacou látkou Menveo zostalo konštantné od 21. mesiaca do 5. roku po očkovaní a hodnota hSBA proti séroskupine
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
Slovak: 1:8 v týchto dvoch vekových skupinách 1 % - 5 % pri séroskupine A, 13 % - 28 % pri séroskupine C, 42 % - 64 % pri séroskupine
English: GSK Vaccines S.r.l., Bellaria-Rosia, 53018 Sovicille (Siena), Italy
Slovak: Bellaria-Rosia, 53018
English: The solution is a colourless clear solution.
Slovak: Roztok je bezfarebný číry roztok.
English: Menveo hSBA ≥ 1:8
Slovak: 1:8 a GMT.
English: Menveo can be given concomitantly with any of the following vaccines: monovalent and combined hepatitis A and B, yellow fever, typhoid fever (Vi polysaccharide), Japanese encephalitis, rabies and meningococcal group B (Bexsero).
Slovak: A a B, žltej zimnici, týfusu (Vi polysacharid), japonskej encefalitíde, besnote a menigokokom skupiny B (Bexsero).
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).
Slovak: Aby sa zaistili optimálne hladiny protilátok proti všetkým séroskupinám očkovacej látky, základná očkovacia schéma očkovacou látkou Menveo sa má dokončiť jeden mesiac pred rizikom expozície baktérii
English: Among Menveo recipients, 58.9%, 16.4%, 21.3% and 3.4% were in the 11-18 year, 19-34 year, 35-55 year and 56-65 year age groups, respectively.
Slovak: Spomedzi osôb, ktoré dostali očkovaciu látku Menveo, bolo 58,9 % vo vekovej kategórii 1118 rokov, 16,4
English: Meningococcal group W-135 oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3-8.3 micrograms
Slovak: 5 mikrogramov oligosacharidov meningokokovej skupiny W-135 konjugovaných na 3,3 - 8,3 mikrogramov proteínu CRM197 Corynebacterium diphtheriae
English: Immunogenicity in adolescents
Slovak: Imunogenita u dospievajúcich
English: Water for injections
Slovak: Chlorid sodný Voda na injekciu
English: W-135 N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
Slovak: W-135 N=96 N=96
English: Percentages of subjects with hSBA≥1:8
Slovak: Percento účastníkov s hSBA ≥
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.
Slovak: Pretrvávanie protilátok v 5. roku po základnom očkovaní bolo hodnotené v štúdii V59P20E1.
English: Booster vaccination
Slovak: GSK Vaccines
English: Uncommon: dizziness
Slovak: Menej časté: závrat
English: Menveo ACWY-PS
Slovak: Menveo ACWY-P
English: Very common: irritability, malaise, injection site pain, injection site erythema (≤50 mm), injection site induration (≤50 mm)
Slovak: Veľmi časté: podráždenosť, malátnosť, bolesť v mieste podania injekcie, erytém v mieste podania injekcie (≤
English: The vaccine is usually given into the upper arm muscle (deltoid) for children (from 2 years of age), adolescents and adults.
Slovak: Očkovacia látka sa deťom (od 2 rokov), dospievajúcim a dospelým zvyčajne podáva do svalu ramena
English: GMT (95% CI)
Slovak: GMT (95
English: MARKETING AUTHORISATION NUMBERS EU/1/10/614/002
Slovak: EU/1/10/614/002
English: GlaxoSmithKline, S.A. Tel: + 34 900 202 700 es-ci@gsk.com
Slovak: Tel: + 34 900 202 700 es-ci@gsk.com
English: Non-clinical data reveal no special hazard for humans based on conventional repeated-dose and reproductive and developmental toxicity studies.
Slovak: Predklinické údaje získané na základe obvyklých štúdií toxicity po opakovanom podávaní,
English: Both groups showed a robust response to the booster dose of Menveo at one month after vaccination (100% of subjects had hSBA ≥ 1:8 across serogroups) and this response largely persisted through 2 years after the booster dose for serogroups C, W-135 and Y (with 87% to 100% of subjects with hSBA ≥ 1:8 across serogroups).
Slovak: 1:8 medzi séroskupinami) a táto odpoveď vo veľkej miere pretrvávala počas 2 rokov po posilňovacej dávke pri séroskupinách C, W-135 a Y (87
English: CI) A N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
Slovak: N=95 N=64 N=64
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menveo solution for injection
Slovak: NÁZOV LIEKU A CESTA (CESTY)
English: GlaxoSmithKline S.p.A. Tel: +39 (0)45 9218 111
Slovak: Tel: +39 (0)45 9218 111
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
Slovak: % a 53 % proti séroskupine Y. Hodnoty GMT boli 6,5 a 12 pri séroskupine C, 19 a 26 pri séroskupine W135 a 8,13 a 10 pri séroskupine Y.
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.
Slovak: Na 7. deň po posilňovacej dávke sa u 98 % - 100 % osôb, ktoré predtým dostali očkovaciu látku Menveo a u 73 % - 84 % osôb, ktoré predtým dostali očkovaciu látku ACWY-PS, dosiahla hodnota hSBA ≥
English: Very common: injection site pain, injection site erythema (≤50 mm), injection site induration
Slovak: Veľmi časté: bolesť v mieste injekcie, erytém v mieste podania injekcie (≤
English: W135 N=279 N=282 N=279 N=282 N=249 N=237 N=249 N=237
Slovak: W135 N=279 N=282
English: • Meningococcal group Y oligosaccharide
Slovak: • Oligosacharid meningokokovej skupiny
English: 5 years
Slovak: 65 rokov.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (0.5 ml)
Slovak: 1 dávka (0,5 ml)
English: In the children 2-10 years of age, as well as in each age strata (2-5 and 6-10 years), immune response as measured by percentage of subjects with seroresponse, hSBA≥1:8 and GMTs were not only non-inferior to comparator vaccine ACWY-PS, but all were statistically higher than the comparator for all serogroups and all immune measurements at 1 month post vaccination.
Slovak: 1:8 a GMT neboli horšie než v prípade porovnávacej očkovacej látky ACWY-PS, ale boli aj štatisticky vyššie než komaprátor pre všetky séroskupiny a všetky imunitné merania 1 mesiac po očkovaní.
English: Serogr oup
Slovak: Sérosk upina
English: C N=281 N=283 N=281 N=283 N=252 N=240 N=252 N=240
Slovak: N=252 N=240 N=252 N=240
English: Timepo int
Slovak: S Menveo
English: hSBA ≥ 1:8
Slovak: 1:8 hSBA GMT
English: These adverse reactions were:
Slovak: Liečivá sú:
English: In the subset of subjects aged 11-18 years who were seronegative at baseline (hSBA < 1:4), the proportion of subjects who achieved a hSBA ≥ 1:8 after a dose of Menveo were as follows: serogroup A 75% (780/1039); serogroup C 80% (735/923); serogroup W-135 94% (570/609); serogroup Y 81% (510/630).
Slovak: C 80 % (735/923); séroskupina W-135 94 % (570/609); séroskupina Y 81
English: Please tell your doctor if you have received a previous injection with Menveo or another meningococcal vaccine.
Slovak: Ak ste v minulosti dostali injekciu očkovacej látky Menveo alebo inej meningokokovej očkovacej látky, povedzte to svojmu lekárovi.
English: Meningococcal group C oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1-12.5 micrograms
Slovak: C konjugovaných na 7,1 - 12,5 mikrogramov proteínu CRM197 Corynebacterium diphtheriae
English: In the non-inferiority study, V59P6, immunogenicity was assessed among adolescents aged 11-17 years who had been randomised to receive either Menveo or ACWY-PS. Menveo was shown to be non-inferior to ACWY-PS vaccine for all four serogroups (A, C, W-135 and Y) based on seroresponse, proportions achieving hSBA ≥1:8, and GMTs.
Slovak: V štúdii non-inferiority V59P6 bola posudzovaná imunogenita medzi dospievajúcimi vo veku 1117 rokov, ktorí boli randomizovaní na podanie očkovacej látky Menveo alebo ACWY-PS.
English: Uncommon: injection site pruritus
Slovak: Menej časté: svrbenie v mieste podania injekcie
English: 5 year persistence 1 month after booster
Slovak: 1 mesiac po posilňovacej dávke
English: At one year post vaccination in these same subjects, compared with ACWY-PS, a higher proportion of subjects vaccinated with Menveo had hSBA ≥1:8 for serogroups C, W-135, and Y, with comparable levels for serogroup A. Similar findings were observed in the comparison of hSBA GMTs.
Slovak: Jeden rok po očkovaní u tých istých osôb v porovnaní s očkovacou látkou ACWY-PS bol väčší podiel osôb s hodnotou hSBA ≥
English: Very common: headache, nausea, injection site pain, injection site redness (≤ 50 mm), injection site firmness (≤ 50 mm), muscle ache, generally feeling unwell
Slovak: Veľmi časté: bolesť hlavy, nevoľnosť, bolesť v mieste vpichu injekcie, začervenanie v mieste vpichu injekcie (≤
English: Common: injection site erythema (>50 mm), injection site induration (>50 mm), fever ≥38°C, chills Uncommon: injection site pruritus
Slovak: triaška, horúčka ≥38 °C Menej časté: svrbenie v mieste podania injekcie
English: Uncommon: dizziness, injection site itching
Slovak: Menej časté: závrat, svrbenie v mieste vpichu injekcie
English: At 5 years after primary vaccination, there were significantly higher percentages of subjects with hSBA ≥ 1:8 in the Menveo group than in the vaccine-naive control subjects against all the four serogroups.
Slovak: V 5. roku po základnom očkovaní bolo signifikantne vyššie percento osôb s hodnotou hSBA ≥
English: Meningococcal group Y oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6-10.0 micrograms.
Slovak: Y konjugovaných na 5,6 - 10,0 mikrogramov proteínu CRM197 Corynebacterium diphtheriae
English: Sero grou p
Slovak: Séros kupin a
English: Common: injection site erythema (>50mm), injection site induration (>50mm), chills, fever ≥38oC
Slovak: 50 mm), bolesť kĺbov, horúčka ≥ 38 °C, triaška
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.
Slovak: 1:8 a GMT i naďalej štatisticky vyššie než ACWY-PS pre séroskupiny A, W-135 a Y.
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).
Slovak: Pri séroskupinách W-135 a Y boli pozorované vyššie hodnoty hSBA GMT (tabuľka 7).
English: Serog roup
Slovak: Pri séroskupine
English: Even if you have been vaccinated with Menveo you remain at increased risk of disease caused by the Neisseria meningitidis groups A, C, W-135 and Y bacteria.
Slovak: - dostávate liek, ktorý bráni tomu, aby v rámci imunitného systému prebiehal proces nazývaný aktivácia komplementu, ako napríklad ekulizumab.V tomto prípade vám naďalej hrozí zvýšené riziko ochorenia spôsobeného baktériami Neisseria meningitidis skupín A, C, W-135 a Y,
English: Menveo Menveo ACWYPS
Slovak: Menveo ACWYPS Menveo ACWY-P
English: Menveo ACWYPS Menveo ACWY-P S Menveo ACWYPS Menveo ACWY-PS A N=280 N=281 N=280 N=281 N=253 N=238 N=253 N=238
Slovak: ACWYPS A N=280
English: Common: rash
Slovak: Časté: vyrážka
English: Meningococcal group A oligosaccharides 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7-33.3 micrograms
Slovak: A konjugovaných na 16,7 - 33,3 mikrogramov proteínu CRM197 Corynebacterium diphtheriae
English: Disodium phosphate dihydrate
Slovak: Corynebacterium diphtheriae
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - POWDER IN VIAL AND SOLUTION IN VIAL
Slovak: ŠKATUĽA - PRÁŠOK V LIEKOVKE A ROZTOK V LIEKOVKE
English: A small decline was observed in percentages of subjects with hSBA ≥ 1:8 against serogroup A, although percentages were still high (77% to 79%).
Slovak: Malý pokles bol pozorovaný v percentáchosôb s hodnotou hSBA
English: PS
Slovak: S
English: • Meningococcal group A oligosaccharide
Slovak: 10 mikrogramov oligosacharidov meningokokovej skupiny
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.
Slovak: Preskúmanie liekov Protelos/Osseor sa začalo v máji 2013 na žiadosť Európskej komisie podľa článku 20 nariadenia (ES)
English: Background information
Slovak: Informácie pre pacientov
English: Overall summary of the scientific evaluation of Protelos/Osseor by the PRAC
Slovak: „Výbor CHMP súhlasil s celkovým posúdením rizík lieku Protelos/Osseor výborom PRAC.
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.
Slovak: Liek Protelos/Osseor sa nesmie používať u pacientov s potvrdenou aktuálnou alebo predchádzajúcou anamnézou ischemickej choroby srdca, s ochorením periférnych artérií a/alebo s cerebrovaskulárnym ochorením, ani u pacientov s nekontrolovanou hypertenziou;
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.
Slovak: Pri rozhodovaní, ako sa má liek Protelos/Osseor používať, výbor CHMP vzal na vedomie analýzu prínosu a rizika lieku, ktorú uskutočnil výbor PRAC, ako aj odporúčanie odborníkov na osteoporózu, že existuje skupina pacientov, pre ktorých by tento liek mohol byť prínosom.
English: It has to be noted that there was a plausible rationale for the selection of this subgroup.
Slovak: Treba poznamenať, že spoločnosť bola požiadaná, aby uskutočnila ďalší výskum na preukázanie účinnosti týchto nových opatrení.
English: In these studies, a statistically significant increase of serious cardiac disorders of 4 events per 1000 PY was observed for the strontium ranelate treated group compared with placebo.
Slovak: Na základe výsledkov sa preukázalo zvýšené riziko infarktu myokardu pri použití lieku Protelos/Osseor v porovnaní s placebom (1,7
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.
Slovak: Liek Protelos/Osseor sa má používať iba na liečbu závažnej osteoporózy u žien po menopauze a u mužov s vysokým rizikom fraktúry, pre ktorých liečba inými liekmi, ktoré sú povolené na liečbu osteoporózy, nie je možná, napríklad vzhľadom na kontraindikácie alebo intoleranciu;
English: In the pooled clinical trial population of postmenopausal women (PMO patients dataset, n=7572) encompassing 3803 patients treated with strontium ranelate (11270 patient years) the odds ratio [95%CI] for myocardial infarction (MI) in strontium ranelate treated versus placebo treated patients was 1.60 [1.07; 2.38], p=0.020.
Slovak: %) s relatívnym rizikom 1,6 (95 % IS, 1,07 až 2,38) a zvýšené riziko venóznych trombotických a embolických udalostí - 1,9 % verzus 1,3
English: Scientific conclusions
Slovak: Informácie pre zdravotníckych pracovníkov
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.
Slovak: Výbor CHMP usúdil, že kardiovaskulárne riziko u pacientov užívajúcich liek Protelos/Osseor možno riadiť obmedzením použitia lieku na pacientov bez anamnézy problémov so srdcom a obehových problémov a obmedzením použitia lieku na pacientov, ktorí nemôžu užívať iné lieky povolené na liečbu osteoporózy.
English: Scientific discussion
Slovak: Liečba liekom
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.
Slovak: Liek Protelos/Osseor (stroncium ranelát) je v EÚ povolený na liečbu závažnej osteoporózy (ochorenia spôsobujúceho krehkosť kostí) u žien po menopauze, ktoré majú vysoké riziko fraktúry (zlomeniny kostí), na zníženie rizika fraktúr chrbtice a bedra.