natgillin/translations-raw huggingface dataset:
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 dni po cepljenju je 64 % oseb doseglo hSBA ≥ 1 : 8 proti seroskupini A in 88 % do 90 % oseb je imelo baktericidna protitelesa proti seroskupinam C, W-135 in Y. Po enem mesecu po cepljenju je imelo 92 % do 98 % oseb hSBA ≥ 1 : 8 proti seroskupinam A, C, W-135 in Y. Opazili so tudi zanesljiv imunski odziv, merjen z GMT hSBA proti vsem seroskupinam, po 7 dneh (GMT 34 do 70) in 28 dneh (GMT 79 do 127) po cepljenju z enkratnim odmerkom.
Individuals 11 to 65 years of age 
Pri osebah, starih 19-55 let,
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. 
V populaciji, stari 11-18 let, so v osrednji študiji V59P13 primerjali imunogenost enojnega odmerka cepiva Menveo en mesec po cepljenju z ACWY-D.
Separate injection sites must be used if more than one vaccine is being administered at the same time. 
Če se sočasno aplicira več kot eno cepivo, je treba izbrati ločeni mesti injiciranja.
The powder is a white to off- white cake. 
Bela do belkasta pogača praška.
At 1 year post last vaccination, the percentages of subjects with hSBA ≥1:8 after the 2-dose series and the single dose were both lower than at 1 month post-vaccination (30% after the 2-dose series, 11%20% after the single dose for serogroup A; 61%-81% and 41%-55% for serogroup C; 92%-94% and 90%-91% for serogroup W-135; 67%-75% and 57%-65% for serogroup Y). 
Eno leto po zadnjem cepljenju so bili odstotki oseb s hSBA ≥ 1:8 po seriji z dvema odmerkoma in z enkratnim odmerkom v obeh skupinah nižji kot en mesec po cepljenju (30 % po seriji z dvema odmerkoma, 11 %-20 % po enkratnem odmerku pri seroskupini A; 61 %-81 % in 41 %-55 % pri seroskupini C; 92 %-94 % in 90 %-91 % pri seroskupini W-135; 67 %-75 % in 57 %-65 % pri seroskupini Y).
Table 4: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 11-18 years 
Tabela 4: Odzivi baktericidnih protiteles v serumu en mesec po cepljenju s cepivom Menveo pri osebah, starih 11-18 let
Table 1: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 2-5 years and 6-10 years 
Tabela 1: Odzivi baktericidnih protiteles v serumu en mesec po cepljenju s cepivom Menveo pri osebah, starih 2-5 let in 6-10 let
Potassium dihydrogen phosphate 
Prašek saharoza kalijev dihidrogenfosfat
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). 
Vsak odmerek cepiva Menveo je na voljo kot: - 1 viala, ki vsebuje komponento liofiliziranega konjugata MenA kot bel do belkast prašek
Musculoskeletal and connective tissue disorders: Common: myalgia, arthralgia General disorders and administration site conditions: 
Bolezni mišično-skeletnega sistema in vezivnega tkiva: Pogosti: mialgija, artralgija
4.7 Effects on ability to drive and use machines 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
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). 
ki so bile ob izhodišču seronegativne, je bil delež oseb, ki so po prvem odmerku cepiva Menveo dosegle hSBA ≥ 1:8, kot sledi: seroskupina A 67 % (582/875); seroskupina C 71 % (401/563); seroskupina W-135 82 % (131/160); seroskupina Y 66 % (173/263).
The solution is a colourless clear solution. 
Raztopina je brezbarvna bistra raztopina.
Overall 3464 subjects aged 2 to10 years were exposed to Menveo in completed clinical trials. 
V zaključenih kliničnih študijah je bilo cepivo Menveo uporabljeno pri skupno 3.464 osebah,
Table 9: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 19-55 years 
Tabela 9: Odzivi baktericidnih protiteles v serumu en mesec po cepljenju s cepivom Menveo pri osebah, starih 19-55 let
The characterization of the safety profile of Menveo in children 2 to 10 years of age is based on data from four clinical trials in which 3181 subjects received Menveo. 
temelji na podatkih štirih kliničnih študij, v katerih je bilo s cepivom Menveo cepljenih 3.181 oseb.
There are limited data in individuals aged 56-65 and there are no data in individuals aged >65 years. 
Pri odraslih, starih med 56 in 65 let, je na voljo le malo podatkov, za odrasle, starejše od 65 let, pa podatkov ni.
Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine 
Menveo prašek in raztopina za raztopino za injiciranje Konjugirano cepivo proti meningokokom skupin A, C, W-135 in Y
Your doctor will tell you if you need an additional injection of Menveo. 
Povedal vam bo, če se morate cepiti še enkrat.
Currently available data are not sufficient to establish the efficacy of Menveo in children under 2 years of age. 
Trenutno razpoložljivi podatki ne zadostujejo za dokaz učinkovitosti cepiva
The two primary safety studies were randomised, active-controlled trials that enrolled participants aged 11 to 55 years (N=2663) and 19 to 55 years (N=1606), respectively. 
V eno so bile vključene osebe, stare 11 do 55 let (n = 2663) in v drugo osebe,
Uncommon: dizziness, injection site itching 
Občasni: omotica, srbenje na mestu injiciranja
Immune system disorders 
- imate oslabljen imunski sistem.
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. 
Po 7 dneh po poživitvenem odmerku je 98 %-100 % oseb, ki so predhodno prejele cepivo Menveo, in 73 %-84 % oseb, ki so predhodno prejele cepivo ACWY-PS, doseglo hSBA ≥ 1 : 8 proti seroskupinam A, C, W-135 in Y. Po enem mesecu po cepljenju je bil odstotek oseb s hSBA ≥ 1 : 8 98 %-100 % oziroma 84 %-96 %.
As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section 5.1). 
Kot pri vsakem drugem cepivu zaščitni imunski odziv morda ne bo dosežen pri vseh cepljenih osebah
Concomitant vaccines should always be administered at separate injection sites and preferably contralateral. 
Druga, sočasno uporabljena cepiva je treba vedno aplicirati na drugo mesto, po možnosti na nasprotni strani telesa.
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. 
Tudi če ste bili cepljeni s cepivom Menveo, imate še vedno večje tveganje za bolezen, ki jo povzročajo bakterije Neisseria meningitidis skupin A, C, W-135 in Y. Kot odziv na vbod z iglo se lahko pojavijo omedlevica, omotica ali druge s stresom povezane reakcije.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menveo powder for injection 
IME ZDRAVILA IN POT(I) UPORABE Menveo raztopina za injiciranje konjugat MenCWY intramuskularna uporaba
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. 
Na začetku študije so bili odstotki oseb s hSBA ≥ 1:8 pri obeh starostnih skupinah: 1 %-5 % pri seroskupini A, 13 %-28 % pri seroskupini C, 42 %-64 % pri seroskupini W-135 in 6 %-19 % pri seroskupini Y. En mesec po zadnjem cepljenju so bili odstotki oseb s hSBA ≥ 1:8 po seriji z dvema odmerkoma in z enkratnim odmerkom pri obeh starostnih skupinah: 90 %-95 % v primerjavi s 76 %-80 % pri seroskupini A, 98 %-99 % v primerjavi s 76 %-87 % pri seroskupini C, 99 % v primerjavi s 93 %-96 % pri seroskupini W-135 in 96 % v primerjavi s 65 %-69 % pri seroskupini Y. Geometrične povprečne vrednosti so bile v obeh starostnih skupinah višje v skupini z dvema odmerkoma kot v skupini z enkratnim odmerkom en mesec po cepljenju, vendar pa je bila ta razlika manj izrazita v starejši skupini.
Talk to your doctor or nurse before you or your child are given Menveo if you or your child: - have a weakened immune system. 
Preden vas ali vašega otroka cepijo s cepivom Menveo, se posvetujte z zdravnikom ali medicinsko sestro, če vi ali vaš otrok:
These include the following vaccines: tetanus, reduced diphtheria and acellular pertussis (Tdap), human papillomavirus (HPV), yellow fever, typhoid fever (Vi polysaccharide), Japanese encephalitis, rabies, hepatitis A and B and meningococcal group B (Bexsero). 
cepivo proti rumeni mrzlici, cepivo proti tifusni vročici (polisaharid Vi), cepivo proti japonskem encefalitisu, cepivo proti steklini, cepivo proti hepatitisu A, cepivo proti hepatitisu B in cepivo proti meningokokom skupine B (Bexsero).
Serogroup hSBA ≥1:8 
Seroskupina hSBA ≥1:8
NAME OF THE MEDICINAL PRODUCT Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine 
Navodilo za uporabo Menveo prašek in raztopina za raztopino za injiciranje konjugirano cepivo proti meningokokom skupin A, C, W-135 in Y
• Meningococcal group Y oligosaccharide 
• Oligosaharid meningokoka skupine Y
Menveo does not protect against diphtheria. 
Cepivo Menveo ne ščiti pred davico.
W-135 N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60 
W135 N=96 N=96 N=95 N=95 N=64 N=64 N=60
• Meningococcal group A oligosaccharide 
• Oligosaharid meningokoka skupine A
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. 
Eno leto po cepljenju je bil delež oseb, cepljenih s cepivom Menveo, s hSBA ≥1:8 višji v primerjavi s cepivom ACWY-PS, za seroskupine C, W-135 in Y, s primerljivimi ravnmi za seroskupino A. Podobni so tudi izsledki primerjave GMT hSBA.
Meningococcal group W-135 oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3-8.3 micrograms 
Oligosaharidi meningokoka skupine W-135, 5 mikrogramov, vezani na beljakovino CRM197 bakterije Corynebacterium diphtheriae, 3,3-8,3 mikrograma
C N=96 N=96 N=94 N=94 N=64 N=64 N=60 N=60 
C N=96 N=96 N=94 N=94 N=64 N=64 N=60
Reconstitution of the vaccine 
Shranjevanje cepiva Menveo
Very common: headache, nausea, injection site pain, injection site redness (≤ 50 mm), injection site firmness (≤ 50 mm), muscle ache, generally feeling unwell 
Zelo pogosti: glavobol, slabost, bolečina na mestu injiciranja, rdečina na mestu injiciranja (≤ 50 mm), otrdelost na mestu injiciranja (≤ 50 mm), bolečina mišic, splošno slabo počutje
Y N=96 N=96 N=94 N=94 N=64 N=64 N=59 N=59 
Y N=96 N=96 N=94 N=94 N=64 N=64 N=59
Skin and subcutaneous tissue disorders: 
Zelo pogosti: navzea Bolezni kože in podkožja:
Very common: irritability, malaise, injection site pain, injection site erythema (≤50 mm), injection site induration (≤50 mm) 
Zelo pogosti: razdražljivost, splošno slabo počutje, bolečina na mestu injiciranja, eritem na mestu injiciranja (≤ 50 mm), otrdlina na mestu injiciranja (≤ 50 mm)
Skin and subcutaneous tissue disorders: Common: rash 
Bolezni mišično-skeletnega sistema in vezivnega tkiva: Zelo pogosti: mialgija
QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml of the reconstituted vaccine) contains: (Originally contained in the powder) 
Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo Menveo En odmerek (0,5 ml rekonstituiranega cepiva) vsebuje:
Meningococcal group C oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1-12.5 micrograms 
Oligosaharidi meningokoka skupine C, 5 mikrogramov, vezani na beljakovino CRM197 bakterije Corynebacterium diphtheriae, 7,1-12,5 mikrograma
Meningococcal group A oligosaccharides 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7-33.3 micrograms 
Oligosaharidi meningokoka skupine A, 10 mikrogramov, vezane na beljakovino CRM197 bakterije Corynebacterium diphtheriae, 16,7-33,3 mikrograma
Persistence of immune response and booster response in adolescents 
Obstojnost imunskega odziva in odziv po poživitvenem odmerku pri otrocih, starih od 2 do 10 let
Serog roup 
Seroskupina
Common: injection site erythema (>50 mm), injection site induration (>50 mm), fever ≥38°C, chills Uncommon: injection site pruritus 
Pogosti: eritem na mestu injiciranja (> 50 mm), otrdlina na mestu injiciranja (> 50 mm), zvišana telesna temperatura ≥ 38 °C, mrzlica Občasni: pruritus na mestu injiciranja
Percentages of subjects with hSBA≥1:8 
Odstotek oseb s hSBA ≥ 1 : 8
For children 2 to 10 years of age, no data are available for evaluating safety and immunogenicity of other childhood vaccines when administered concomitantly with Menveo. 
Podatkov o varnosti in imunogenosti drugih otroških cepiv, ki se dajejo sočasno s cepivom Menveo,
12 mont hs 
12 mesec ev
Uncommon: dizziness 
Občasni: omotica
Meningococcal group Y oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6-10.0 micrograms. 
Oligosaharidi meningokoka skupine Y, 5 mikrogramov, vezani na beljakovino CRM197 bakterije Corynebacterium diphtheriae, 5,6-10,0 mikrograma
CI) A N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60 
A N=96 N=96 N=95 N=95 N=64 N=64 N=60
P Value Menveo vs ACWYPS 
P-vrednost cepiva Men veo v primerjav i z ACWY-PS
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 
Ugotovili so prisotnosti protiteles proti seroskupinam C, W-135 in Y, pri čemer je bil delež oseb z vrednostjo hSBA ≥ 1:8 za seroskupino C 32 % v starostni skupini 2-5 let in 56 % v starostni skupini 6-10 let, za seroskupino W-135 74 % v starostni skupini 2-5 let in 80 % v starostni skupini 6-10 let, in za seroskupino Y 48 % v starostni skupini 2-5 let in 53 % v starostni skupini 6-10 let.
CI) 
IZ)
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. 
Imunski odziv, ki so ga opazili pri otrocih, starih 2-10 let, je bil podoben kot pri študiji V59P8, kot je prikazano zgoraj: imunski odziv na cepivo
Very common: 
Zelo pogosti: Pogosti:
ACWY-PS for all four serogroups and statistically superior for serogroups A and Y (Table 10). 
Razmerje oseb s titri hSBA ≥ 1:8 ni bilo inferiorno kot pri ACWY-PS za vse štiri seroskupine, za skupini A in Y pa je bilo statistično boljše (tabela 10).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENA LYOPHILISED CONJUGATE COMPONENT 
VIALA OZNAKA SESTAVINA S TEKOČIM KONJUGATOM MENCWY
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. 
ki so dobili cepivo Menveo (n = 216) so bile podobne tistim, ki so jih opazili pri osebah, cepljenih s cepivom Menveo, starih med 11-55 let.
Menveo Menveo ACWY-P S 
ACWYPS Menveo ACWYPS Menveo ACWY-PS
and 6-10 years of age, respectively, had hSBA ≥ 1:8 (GMTs 2.95 and 3.73). 
Delež oseb z vrednostjo hSBA ≥ 1:8 za seroskupino A je bil 14 % (GMT 2,95) v starostni skupini 2-5 let in 22 % (GMT 3,73) v starostni skupini 6-10 let.
All subjects in both age groups had hSBA ≥ 1:8 across all serogroups, with antibody titers several fold higher than seen after the primary vaccination (Table 3). 
Pri vseh osebah je bila v obeh starostnih skupinah vrednost hSBA ≥ 1:8 za vse seroskupine,
How to use Menveo 
Način uporabe
Sodium dihydrogen phosphate monohydrate 
Raztopina natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat dihidrat natrijev klorid voda za injekcije
Menveo contains 
Cepivo Menveo vsebuje
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). 
5 let po cepljenju je odstotek prejemnikov cepiva Menveo s hSBA ≥ 1:8 za seroskupini C in Y ostal značilno večji v primerjavi s prejemniki cepiva ACWY-PS.
Common: rash, injection site redness (> 50 mm), injection site firmness (> 50 mm), joint ache, fever ≥ 38°C, chills 
Pogosti: izpuščaj, rdečina na mestu injiciranja (>50 mm), otrdelost na mestu injiciranja (>50 mm), bolečina sklepov, zvišana telesna temperatura ≥ 38 °C, mrzlica
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) 
slabost, bruhanje, driska, izpuščaj, bolečina mišic, bolečina sklepov, mrzlica, zvišana telesna temperatura ≥ 38 °C, rdečina na mestu injiciranja (>50 mm) in otrdelost na mestu injiciranja (>50 mm)
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 
A n = 280 n = 281 n = 280 n = 281 n = 253 n = 238 n = 253 n = 238
P Value Menveo vs 
Pred poživitveni m odmerkom
hSBA ≥ 1:8 (95% CI) 
GMT hSBA (95 % I Z)
Powder 
KG
Intramuscular use 
Poživitveni odmerek
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENCWY LIQUID CONJUGATE COMPONENT 
OVOJNINAH VIALA OZNAKA SESTAVINA LIOFILIZIRANEGA KONJUGATA MENA
Common: injection site erythema (>50mm), injection site induration (>50mm), chills, fever ≥38oC 
Pogosti: eritem na mestu injiciranja (> 50 mm), otrdlina na mestu injiciranja (> 50 mm), mrzlica,
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. 
Pokazalo se je, da cepivo Menveo ni inferiorno od cepiva ACWY-PS za vse štiri seroskupine (A, C, W-135 in Y) na podlagi serološkega odziva, razmerij v doseganju hSBA ≥1:8 in za GMT.
Metabolism and nutrition disorders: 
Ti neželeni učinki so bili: Presnovne in prehranske motnje:
5 year persistence 1 month after booster 
1 mesec po poživitvenem odmerku
GlaxoSmithKline GmbH & Co. KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com 
Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
Sero grou p 
Seros kupin a
Very common: injection site pain, injection site erythema (≤50 mm), injection site induration 
Zelo pogosti: bolečina na mestu injiciranja, eritem na mestu injiciranja (≤50 mm), otrdlina na mestu injiciranja (≤ 50 mm), splošno slabo počutje
No effects on fertility were observed in female rabbits receiving Menveo pre-mating and during pregnancy. 
Pri samicah kuncev, cepljenih s cepivom Menveo pred paritvijo in med brejostjo, niso opazili vpliva na sposobnost razmnoževanja.
• 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. 
Pregled zdravila Protelos/Osseor se je začel maja 2013 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
Background information 
Informacije za bolnike
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. 
Rezultati so pokazali povečano tveganje za miokardni infarkt pri uporabi zdravila Protelos/Osseor v primerjavi s placebom (1,7 % v primerjavi z 1,1 %) z relativnim tveganjem 1,6 (95-odstotni IZ, 1,07 do 2,38) in povečano tveganje za venske trombotične in embolične dogodke1,9 % v primerjavi z 1,3 %, z relativnim tveganjem 1,5 (95-odstotni IZ, 1,04 do 2,19).
Overall summary of the scientific evaluation of Protelos/Osseor by the PRAC 
„Odbor CHMP se je strinjal s splošno oceno tveganj, povezanih z zdravilom Protelos/Osseor, ki jo je podal odbor PRAC.
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. 
Pri sprejemanju odločitve glede uporabe zdravila Protelos/Osseor je odbor CHMP upošteval analizo koristi in tveganj, ki jo je izvedel odbor PRAC, ter mnenje strokovnjakov za osteoporozo, da obstaja skupina bolnikov, ki bi jim zdravilo lahko koristilo.
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. 
Razpoložljivi podatki ne kažejo povečanega srčno-žilnega tveganja pri bolnikih brez ugotovljene obstoječe ali pretekle ishemične bolezni srca, periferne arterijske bolezni in/ali možgansko-žilne bolezni ter pri bolnikih z nenadzorovano hipertenzijo.
Scientific conclusions 
Informacije za zdravstvene delavce
Overall conclusion 
Več o postopku
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. 
• Zdravilo Protelos/Osseor se lahko uporablja samo za zdravljenje hude osteoporoze pri ženskah po menopavzi in moških z velikim tveganjem za zlome, pri katerih zdravljenje z drugimi zdravili, odobrenimi za zdravljenje osteoporoze, ni mogoče, na primer zaradi kontraindikacij ali intolerance.