natgillin/translations-raw huggingface dataset:
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menveo powder for injection 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Menveo prašak za injekciju MenA konjugat
Potassium dihydrogen phosphate 
Prašak saharoza kalijev dihidrogenfosfat
Table 2: Immunogenicity of one dose of Menveo or ACWY-PS in subjects 2 through 10 years of age, measured at one month and twelve months post-vaccination 
Tablica 2: Imunogenost jedne doze cjepiva Menveo ili ACWY-PS u ispitanika u dobi od 2 do 10 godina, mjerena jedan mjesec te dvanaest mjeseci nakon cijepljenja
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENA LYOPHILISED CONJUGATE COMPONENT 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI KOJA SADRŽI LIOFILIZIRANI MENA KONJUGAT
A booster dose of Menveo was administered 3 years after primary vaccination with Menveo or ACWY-D. 
Docjepljivanje cjepivom Menveo primijenjeno je 5 godine nakon prvog cijepljenja cjepivom Menveo ili cjepivom ACWY-PS.
Serogrou p 
Serogrup a
Uncommon: dizziness 
Nepoznato: vrtoglavica
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. 
U populaciji staroj od 11 do 18 godina u pivotalnom ispitivanju V59P13, imunogenost pojedinačne doze cjepiva Menveo mjesec dana nakon cijepljenja uspoređena je s ACWY-D.
Very common: myalgia 
Vrlo često: mialgija Često: artralgija
6.6 Special precautions for disposal and other handling Menveo must be prepared for administration by reconstituting powder (in vial) with solution (in vial). 
Menveo se mora pripremiti za primjenu rekonstituiranjem praška (u bočici) s otopinom (u bočici).
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 
Na početku ispitivanja, postotak ispitanika sa hSBA ≥1:8 u obje dobne skupine bio je 1%-5% za serogrupu A, 13%-28% za serogrupu C, 42%-64% za serogrupu W-135 i 6%-19% za serogrupu Y.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menveo solution for injection 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Menveo otopina za injekciju MenCWY konjugat
It is possible that the effectiveness of Menveo could be reduced in such individuals. 
Postoji mogućnost da je učinkovitost cjepiva
In children (from 2 to 10 years of age), the side effects that were reported during clinical trials are listed below. 
Nuspojave prijavljene tijekom kliničkih ispitivanja u djece (u dobi od 2 do 10 godina) navedene su u nastavku.
- ever had an allergic reaction to the active substances or any of the other ingredients of this vaccine (listed in section 6) - ever had an allergic reaction to diphtheria toxoid (a substance used in a number of other vaccines) - an illness with high fever. 
Vi ili Vaše dijete primite Menveo Nemojte primjenjivati Menveo ako ste Vi ili Vaše dijete: - imali alergijsku reakciju na djelatne tvari ili neki drugi sastojak ovog cjepiva (naveden u dijelu 6.) - imali alergijsku reakciju na toksoid difterije (tvar koja se koristi u drugim cjepivima)
In the pivotal, randomised, observer-blind study V59P20, in which participants were stratified by age (2 through 5 years and 6 through 10 years), the immunogenicity of a single dose of Menveo one month post vaccination was compared with the single dose of ACWY-D. Immunogenicity results one month after Menveo vaccination among subjects aged 2-5 years and 6-10 years are summarized below in Table 1 
U pivotalnom, randomiziranom, za ocjenitelja slijepom ispitivanju V59P20, u kojem su ispitanici bili stratificirani prema dobi (od 2 do 5 godina i od 6 do 10 godina), imunogenost pojedinačne doze cjepiva Menveo mjesec dana nakon cijepljenja uspoređena je s pojedinačnom dozom cjepiva ACWY-D.
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. 
imunološki odgovori, određeni prema postotku ispitanika sa serološkim odgovorom hSBA≥1:8 i GMTs, nisu bilo samo neinferiorni u odnosu na usporedno cjepivo ACWY-PS, već su bili statistički viši od usporednog cjepiva za sve serogrupe i u svim imunološkim mjerenjima mjesec dana nakon cijepljenja.
How to store Menveo 
Moguće nuspojave Kako čuvati Menveo
While Human Immunodeficiency Virus (HIV) infection is not a contraindication, Menveo has not been specifically evaluated in immunocompromised people. 
Obzirom da infekcija virusom humane imunodeficijencije (HIV) nije kontraindikacija,
What you need to know before you or your child are given Menveo 
Vi ili Vaše dijete primite Menveo Kako primjenjivati Menveo
Table 1: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 2-5 years and 6-10 years 
Tablica 1: Odgovori serumskih baktericidnih protutijela mjesec dana nakon cijepljenja cjepivom Menveo u ispitanika u dobi od 2 do 5 godina i 6 do 10 godina
In two supportive studies V59P8 and V59P10 immunogenicity of Menveo was compared to ACWY-PS. 
V59P8 i V59P10, uspoređena je imunogenost cjepiva Menveo s ACWY-PS.
Conjugated to Corynebacterium diphtheriae CRM197 protein 
Konjugiran na protein CRM197 Corynebacterium diphtheriae
Excipients: Potassium dihydrogen phosphate, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, water for injection. 
POPIS POMOĆNIH TVARI Pomoćne tvari: kalijev dihidrogenfosfat, saharoza, natrijev klorid, natrijev dihidrogenfosfat hidrat,
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. 
Godinu dana nakon cijepljenja Menveo je imao i dalje statistički viši imunološki odgovor od cjepiva ACWY-PS za serogrupe A, W-135 i Y prema mjerenjima postotka ispitanika s hSBA≥1:8 i GMTs.
Table 4: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 11-18 years 
Tablica 4: Odgovori serumskih baktericidnih protutijela mjesec dana nakon cijepljenja cjepivom Menveo u ispitanika u dobi od 11 do 18 godina
Table 9: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 19-55 years 
Tablica 9: Odgovori serumskih baktericidnih protutijela mjesec dana nakon cijepljenja cjepivom Menveo u ispitanika u dobi od 19 do 55 godina
If a vaccine recipient is undergoing immunosuppressant treatment, the immunological response may be diminished. 
Imunološki odgovor može biti slabiji ako je bolesnik podvrgnut imunosupresivnoj terapiji.
Metabolism and nutrition disorders: 
Poremećaji metabolizma i prehrane: Često: poremećaji prehrane Poremećaji živčanog sustava:
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. 
Pet godina nakon prvog cijepljenja, skupina koja je primala Menveo imala je znatno veće postotke ispitanika s hSBA ≥ 1:8 od kontrolnih ispitanika koji nisu primili cjepivo protiv sve četiri serogrupe.
Separate injection sites must be used if more than one vaccine is being administered at the same time. 
Ako se u isto vrijeme primjenjuje više od jednog cjepiva, potrebno ih je injicirati na različita mjesta.
It should be checked if the adverse reactions may be intensified by any co-administration. 
Potrebno je provjeriti mogu li se nuspojave pojačati kod istodobne primjene cjepiva Menveo s bilo kojim cjepivom.
Intramuscular use 
Za intramuskularnu primjenu
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). 
Nakon 1 godine od zadnjeg cijepljenja, postotci ispitanika sa hSBA ≥1:8 nakon serije s 2 doze i nakon jednostruke doze bili su niži nego 1 mjesec nakon cijepljenja (30% nakon serije s 2 doze, 11%-20% nakon jednostruke doze za serogrupu A; 61%-81% i 41%-55% za serogrupu C; 92%-94% i 90%-91%
Studies with Menveo have shown a waning of serum bactericidal antibody titers against serogroup A when using human complement in the assay (hSBA) (see section 5.1). 
Ispitivanja s cjepivom Menveo pokazala su smanjenje titra baktericidnih protutijela u serumu protiv serogrupe A u testu s humanim komplementom (engl.
Your doctor or nurse may still recommend that you receive Menveo if you are at high risk of infection with meningococcal group A, C, W-135 and Y bacteria. 
Vam preporučiti da primite Menveo ako ste u visokom riziku od infekcije bakterijama meningokokne grupe A, C, W-135 i Y.
België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. 
België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 10 85 52 00
Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine 
Menveo prašak i otopina za otopinu za injekciju Konjugirano cjepivo protiv meningokoka grupe A, C, W-135 i Y
Immune system disorders 
Poremećaji imunološkog sustava:
Menveo is a vaccine that is used for active immunization of children (from 2 years of age), adolescents and adults at risk of exposure to a bacterium named Neisseria meningitidis serogroups A, C, W-135 and Y, to prevent invasive disease. 
Menveo je cjepivo koje se koristi za aktivnu imunizaciju djece (u dobi od 2 i više godine), adolescenata i odraslih s rizikom izlaganja bakteriji pod nazivom Neisseria meningitidis serogrupa A,
- have haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants). 
Menveo smanjena u takvih osoba. - imate hemofiliju ili neki drugi problem koji može spriječiti ispravno zgrušavanje krvi,
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. 
Nakon 1 mjeseca od zadnjeg cijepljenja, postotci ispitanika sa hSBA ≥1:8 u skupini s 2 doze u odnosu na skupinu s jednostrukom dozom u dvjema dobnim skupinama bili su: 90%-95% naspram 76%-80% za serogrupu A, 98%-99% naspram 76%-87% za serogrupu C, 99% naspram 93%-96% za serogrupu W-135 i 96% naspram 65%-69% za serogrupu Y.
Uncommon: injection site pruritus 
Manje često: pruritus na mjestu injiciranja
In adolescents (from 11 years of age) and adults, the most common side effects that were reported during clinical trials are listed below. 
Najčešće nuspojave prijavljene tijekom kliničkih ispitivanja u adolescenata (u dobi od 11 i više godina) i odraslih navedene su u nastavku.
• Meningococcal group A oligosaccharide 
• Oligosaharid meningokokne grupe
Meningococcal group C oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1-12.5 micrograms 
5 mikrograma oligosaharida meningokokne grupe C konjugirano na 7,1-12,5 mikrograma proteina CRM197 Corynebacterium diphtheriae
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. 
≥ 1:8 ostao je znatno veći u usporedbi s primateljima cjepiva ACWY-PS za serogrupe C, W-135 i Y, i sličan između dvije ispitivane skupine za serogrupu A. hSBA GMTs za serogrupe W-135 i Y viši su kod primatelja cjepiva Menveo.
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). 
- 1 bočica koja sadrži liofilizirani MenA konjugat u obliku praška bijele do bjelkaste boje - 1 bočica koja sadrži liofilizirani MenCWY konjugat u obliku bistre otopine
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - POWDER IN VIAL AND SOLUTION IN VIAL 
KARTONSKA KUTIJA - PRAŠAK U BOČICI I OTOPINA U BOČICI
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). 
Pet godina nakon cijepljenja, postotak primatelja cjepiva Menveo s hSBA ≥ 1:8 ostao je znatno veći u usporedbi s primateljima cjepiva ACWY-PS za serogrupe C i Y.
Tel: + 420 2 22 00 11 11 cz.info@gsk.com 
Česká republika GlaxoSmithKline s.r.o. Tel: + 420 2 22 00 11 11 cz.info@gsk.com
Meningococcal group W-135 oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3-8.3 micrograms 
5 mikrograma oligosaharida meningokokne grupe W-135 konjugirano na 3,3-8,3 mikrograma proteina CRM197 Corynebacterium diphtheriae
5 year persistence 1 month after booster 
1 mjesec nakon docjepljivanja
Menveo ACWY-P S 
ACWY-P S
Common: nausea, vomiting, diarrhea 
Često: mučnina, povraćanje, proljev Poremećaji kože i potkožnog tkiva:
Very common: headache, nausea, injection site pain, injection site redness (≤ 50 mm), injection site firmness (≤ 50 mm), muscle ache, generally feeling unwell 
Vrlo često: glavobolja, mučnina, bol na mjestu injiciranja, crvenilo na mjestu injiciranja (≤ 50 mm), otvrdnuće na mjestu injiciranja (≤ 50 mm), bol u mišićima, opće loše stanje
ACWY-PS for all four serogroups and statistically superior for serogroups A and Y (Table 10). 
ACWY-PS za sve serogrupe, a bio je statistički superioran za serogrupe
Menveo is a powder and a solution for injection. 
Kako Menveo izgleda i sadržaj pakiranja Menveo je prašak i otopina za injekciju.
NAME OF THE MEDICINAL PRODUCT Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine 
Uputa o lijeku: Informacije za korisnika Menveo prašak i otopina za otopinu za injekciju Konjugirano cjepivo protiv meningokoka grupe A, C, W-135 i Y
Timepoint 
Vremensk a točka
12 months post-vaccination hSBA ≥1:8 
12 mjeseci nakon cijepljenja hSBA ≥1:8
Common: rash 
Često: osip
and 6-10 years of age, respectively, had hSBA ≥ 1:8 (GMTs 2.95 and 3.73). 
Za serogrupu A, 14% ispitanika u dobi od 2 do 5 godina i 22% ispitanika u dobi od 6 do 10 godina imalo je hSBA ≥1:8 (GMTs 2,95 i 3,73).
3 years 
7 dana
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). 
A 75% (780/1039); serogrupa C 80% (735/923); serogrupa W-135 94% (570/609); serogrupa Y 81% (510/630).
GlaxoSmithKline d.o.o. 
GlaxoSmithKline A.E.B.E
Common: injection site erythema (>50mm), injection site induration (>50mm), chills, fever ≥38oC 
Često: eritem na mjestu injiciranja (>50 mm), otvrdnuće na mjestu injiciranja (>50 mm), vrućica ≥38°C, zimica
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). 
Kako bi se osigurale optimalne razine protutijela protiv svih serogrupa cjepiva, prvo cijepljenje cjepivom Menveo potrebno je dovršiti mjesec dana prije rizika od izlaganja bakteriji
P Value Menveo vs ACWYPS 
P vrijedn ost Menveo naspram ACWYPS
In non-clinical studies, Menveo had no direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. 
embrionalni/fetalni razvoj, porod ili postnatalni razvoj.
The comparative immunogenicity of Menveo vs. ACWY-PS was evaluated in subjects aged 56-65 years, in study V59P17. 
U ispitivanju V59P17 ispitana je komparativna imunogenost cjepiva Menveo u usporedbi s ACWY-PS u ispitanika u dobi od 56 do 65 godina.
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 
Y uz postotak ispitanika s hSBA ≥1:8 protiv serogrupe C od 32% za ispitanike u dobi od 2 do 5 godina i 56% za ispitanike u dobi od 6 do 10 godina, protiv serogrupe W-135 od 74% za ispitanike u dobi od 2 do 5 godina i 80% za ispitanike u dobi od 6 do 10 godina i protiv serogrupe
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. 
Sedam dana nakon docjepljivanja, 98% - 100% ispitanika koji su prethodno cijepljeni cjepivom Menveo i 73% - 84% ispitanika koji su prethodno cijepljeni cjepivom ACWY-PS postigli su hSBA ≥1:8 protiv serogrupa A, C, W-135 i Y.
Very common: injection site pain, injection site erythema (≤50 mm), injection site induration 
Vrlo često: bol na mjestu injiciranja, eritem na mjestu injiciranja (≤50 mm), otvrdnuće na mjestu injiciranja (≤50 mm), malaksalost
Very rare: 
Manje često:
4.7 Effects on ability to drive and use machines 
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Nisu provedena ispitivanja utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.
Menveo Menveo ACWY-P S 
Menveo ACWYPS Menveo ACWY -PS Menveo ACWY-PS
Common: rash, injection site redness (> 50 mm), injection site firmness (> 50 mm), joint ache, fever ≥ 38°C, chills 
Često: osip, crvenilo na mjestu injiciranja (> 50 mm), otvrdnuće na mjestu injiciranja (> 50 mm), bol u zglobovima, vrućica ≥ 38°C, zimica
4.4 Special warnings and precautions for use 
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
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). 
Mjesec dana nakon prvog cijepljenja, postotci ispitanika s hSBA≥1:8 bili su dosljedno viši u skupini koja je primila Menveo za sve četiri serogrupe (63% naspram 39%, 46% naspram 39%, 78%
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
Very common: irritability, malaise, injection site pain, injection site erythema (≤50 mm), injection site induration (≤50 mm) 
Vrlo često: razdražljivost, malaksalost, bol na mjestu injiciranja, eritem na mjestu injiciranja (≤50 mm), otvrdnuće na mjestu injiciranja (≤50 mm) Često: eritem na mjestu injiciranja (>50 mm), otvrdnuće na mjestu injiciranja (>50 mm), zimica, vrućica ≥38°C
hSBA ≥ 1:8 (95% CI) 
hSBA (95% C I)
Reconstitution of the vaccine 
PRIMJENU LIJEKA
Meningococcal group Y oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6-10.0 micrograms. 
Y konjugirano na 5,6-10,0 mikrograma proteina CRM197 Corynebacterium diphtheriae
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. 
Sedam dana nakon cijepljenja, 64% ispitanika postiglo je hSBA ≥1:8 protiv serogrupe A i 88% do 90% ispitanika imalo je baktericidna protutijela protiv serogrupa C, W-135 i Y.
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. 
U ispitivanju neinferiornosti, V59P6, procijenjena je imunogenost u adolescenata u dobi od 11 do 17 godina koji su randomizirani prema primanju cjepiva Menveo ili ACWY-PS.
Meningococcal group A oligosaccharides 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7-33.3 micrograms 
A konjugirano na 16,7-33,3 mikrograma proteina CRM197 Corynebacterium diphtheriae
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. 
Menveo je imao hSBA ≥1:8 za serogrupe C, W-135 i Y, s usporedivim razinama za serogrupu A.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription 
ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
Sodium dihydrogen phosphate monohydrate 
natrijev hidrogenfosfat dihidrat i voda za injekcije.
Tél/Tel: + 32 10 85 52 00 
Tηλ: + 30 210 68 82 100
Background information 
Informacije za bolesnike
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 pokazuju povećan rizik od infarkta miokarda uslijed uzimanja lijekova Protelos/Osseor u usporedbi s placebom (1,7% u odnosu na 1,1 %), s relativnim rizikom od 1,6 (95% CI, 1,07 do 2,38), i povećanim rizikom od venskih trombotskih i embolijskih događaja - 1,9% u odnosu na 1,3 % s relativnim rizikom od 1,5 (95% CI, 1,04 do 2,19).
Scientific conclusions 
Informacije za zdravstvene djelatnike
• 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. 
Uredbe (EZ) br. 726/2004.
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. 
• Lijekovi Protelos/Osseor ne smiju se primjenjivati u bolesnika s utvrđenom, aktualnom ili prošlom ishemijskom bolešću srca, perifernom arterijskom bolesti i/ili cerebrovaskularnom bolesti ili u onih s nekontroliranom hipertenzijom;