natgillin/translations-raw huggingface dataset:
The analysis of immunogenicity was conducted on ATP cohort for persistence adapted for each time-point.
Analizo imunogenosti so opravili na kohorti ATP za trajanje, prilagojeno za vsako časovno točko.
To attach the needle to the syringe, refer to the picture.
Za namestitev igle na brizgo glejte sliko.
In the subgroup aged >65 years the percentage of vaccines with rSBA titres ≥128 at one month post-vaccination ranged from 90% (group A) to 97% (group Y).
V podskupini, stari > 65 let, je delež cepljenih oseb s titri rSBA ≥ 128 en mesec po cepljenju znašal od 90 % (skupina A) do 97 % (skupina Y).
• received your first dose at age 12-23 months and could be at particular risk of infection caused by Neisseria meningitidis types A, C, W-135 and Y
• prvi odmerek prejeli pri starosti od 12 do 23 mesecev in pri vas ali vašem otroku obstaja posebno tveganje za okužbo z Neisserio meningitidis tipov A, C, W-135 in Y.
If Nimenrix is co-administered with other vaccines, different injection sites should be used.
Če je cepivo Nimenrix uporabljeno sočasno z drugimi cepivi, ga je treba injicirati na drugo mesto.
Nimenrix must be reconstituted by adding the entire content of the ampoule of solvent to the vial containing the powder.
Cepivo Nimenrix je treba rekonstituirati tako, da se celotno vsebino ampule z vehiklom doda v vialo s praškom.
Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
Občasni (pojavijo se lahko pri največ 1 na 100 odmerkov cepiva):
Response to Nimenrix in subjects previously vaccinated with a plain polysaccharide vaccine against Neisseria meningitidis
Odziv na cepivo Nimenrix pri preskušancih, predhodno cepljenih z navadnim polisaharidnim cepivom proti Neisseria meningitidis
Nimenrix elicited bactericidal responses against groups W-135 and Y that were higher in terms of % with hSBA titre ≥8 when two doses were given compared with one.
Cepivo Nimenrix je povzročilo baktericidne odzive proti skupinama W-135 in Y, ki so bili (kar zadeva odstotke s titri hSBA ≥ 8) večji pri dveh odmerkih kot pri enem samem.
Common (these may occur with up to 1 in 10 doses of the vaccine):
Pogosti (pojavijo se lahko pri največ 1 na 10 odmerkov cepiva):
Not known: frequency cannot be estimated from the available data • injection site swelling and redness; this may affect a large area of the vaccinated limb
Neznana: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
Neisseria meningitidis group W-135 polysaccharide1
Polisaharid Neisseria meningitidis skupine W-135
What you need to know before you receive Nimenrix Nimenrix should not be given if:
Kaj morate vedeti, preden boste prejeli cepivo Nimenrix
In previously vaccinated individuals 12 months of age and older, Nimenrix may be given as a booster dose if they have received primary vaccination with a conjugated or plain polysaccharide meningococcal vaccine (see sections 4.4 and 5.1).
Cepivo Nimenrix je mogoče dati kot obnovitveni odmerek pri predhodno cepljenih posameznikih, starih 12 mesecev in več, ki so prejeli osnovno cepljenje s konjugiranim ali navadnim polisaharidnim meningokoknim cepivom (glejte poglavji 4.4 in 5.1).
A different injection site will be used for each vaccine.
Vsako cepivo je treba injicirati na drugo mesto.
Overall, at one month post-vaccination the percentage of vaccines with rSBA titres ≥ 128 ranged from 93% (group C) to 97% (group Y).
Skupno je en mesec po cepljenju delež cepljenih oseb s titri rSBA ≥ 128 znašal od 93 % (skupina C) do 97 % (skupina Y).
• stomach and digestion problems such as diarrhoea, vomiting and nausea
• želodčne in prebavne težave, npr. driska, bruhanje in slabost s siljenjem na bruhanje
The mixed vaccine will appear as a clear colourless solution.
Tako zmešano cepivo je bistra, brezbarvna raztopina.
Powder in a vial (type I glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe with a stopper (butyl rubber).
Prašek v viali (steklo tipa I) z zamaškom (butilna guma) in vehikel v napolnjeni injekcijski brizgi z zamaškom (butilna guma).
Persistence of the immune response was evaluated by hSBA 1 year after vaccination in children 6-10 years of age who were initially vaccinated in study MenACWY-TT-027 (Table 11) (see section 4.4).
Trajanje imunskega odziva so ocenili s hSBA 1 leto po cepljenju pri otrocih, starih od 6 do 10 let, ki so prejeli začetno cepljenje v študiji MenACWY-TT-027 (preglednica 11) (glejte poglavje 4.4).
This leaflet was last revised in {MM/YYYY} Other sources of information
Navodilo je bilo nazadnje revidirano
N VR (95% CI)
n VR (95 % IZ)
• received your first dose at age 6-14 months and could be at particular risk of infection caused by Neisseria meningitidis types W-135 and Y
• prvi odmerek prejeli pri starosti od 6 do 14 mesecev in pri vas ali vašem otroku obstaja posebno tveganje za okužbo z Neisserio meningitidis tipov W-135 in Y.
In the second year of life, Nimenrix can also be given concomitantly with combined diphtheriatetanus - acellular pertussis (DTaP) vaccines, including combination DTaP vaccines with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b (HBV, IPV or Hib) such as DTaP-HBVIPV/Hib vaccine, and 13-valent pneumococcal conjugate vaccine.
V drugem letu življenja se cepivo Nimenrix lahko uporabi hkrati s kombiniranimi cepivi proti davicitetanusu-oslovskemu kašlju (brezcelično) (DTaP), vključno s kombinacijo cepiv DTaP s cepivom proti hepatitisu B, otroški paralizi (inaktivirano) ali Haemophilusu influenzae tipa b (HBV, IPV ali Hib), npr. cepivom DTaP-HBV-IPV/Hib, in 13-valentnim pnevmokoknim konjugiranim cepivom.
Nimenrix will only protect against infections caused by the bacteria “Neisseria meningitidis” types A, C, W-135 and Y.
Cepivo Nimenrix zaščiti samo pred okužbami, ki jih povzročajo bakterije “Neisseria meningitidis” tipov A, C, W-135 in Y.
Nimenrix 1 dose
Nimenrix 1 odmerek po 1. odmerku
Immunogenicity in adolescents aged 11-17 years and adults aged ≥ 18 years In two clinical studies, conducted in adolescents 11-17 years of age (study MenACWY-TT-036) and in adults 18-55 years of age (study MenACWY-TT-035), either one dose of Nimenrix or one dose of the ACWY-PS vaccine were administered.
V dveh kliničnih študijah, eni opravljeni pri mladostnikih, starih od 11 do 17 let (študija MenACWYTT-036) in drugi pri odraslih, starih od 18 do 55 let (študija MenACWY-TT-035), so preskušanci prejeli bodisi en odmerek cepiva Nimenrix bodisi en odmerek cepiva ACWY-PS.
≥1:8 and ≥1:128 and hSBA titres ≥1:4 and ≥1:8.
En mesec po prvem odmerku cepiva in en mesec po drugem odmerku je imel v obeh skupinah podoben odstotek preskušancev titre rSBA ≥ 1 : 8 in ≥ 1 : 128 ter titre hSBA ≥ 1 : 4 in ≥ 1 : 8.
Nimenrix booster vaccination in subjects previously primed with a monovalent (MenC-CRM) or a quadrivalent conjugate meningococcal vaccine (MenACWY-TT) was studied in subjects from 12 months of age onwards who received a booster vaccination.
Pri preskušancih, starejših od 12 mesecev, ki so predhodno prejeli osnovno cepljenje z monovalentnim (MenC-CRM) ali tetravalentnim konjugiranim meningokoknim cepivom (MenACWY-TT), so preučevali cepljenje z obnovitvenim odmerkom cepiva Nimenrix.
Shake well before use.
intramuskularna uporaba Pred uporabo dobro pretresite.
Nimenrix will only confer protection against Neisseria meningitidis group A, C, W-135 and Y. The vaccine will not protect against any other Neisseria meningitidis groups.
Cepivo Nimenrix ščiti le pred Neisseria meningitidis skupin A, C, W-135 in Y, ne pa pred drugimi skupinami Neisseria meningitidis.
Nimenrix is supplied as a white powder or cake in a single dose glass vial and a clear and colourless solvent in an ampoule.
Cepivo Nimenrix je na voljo kot bel prašek ali pogača v stekleni viali z enkratnim odmerkom in kot bister in brezbarven vehikel v ampuli.
Powder and solvent for solution for injection in ampoule
prašek in vehikel za raztopino za injiciranje v ampuli
A booster dose might be considered in individuals vaccinated at toddler age remaining at high risk of exposure to meningococcal disease caused by groups A, C, W-135 or Y (see section 5.1).
Pri posameznikih, ki so bili kot malčki cepljeni in pri katerih še vedno obstaja veliko tveganje za izpostavljenost meningokokni bolezni, ki jo povzročajo skupine A, C, W-135 ali Y, se lahko razmisli o obnovitvenem odmerku (glejte poglavje 5.1).
Month 1 356 82.0% (77.6; 85.9) Year 1 350 29.1% (24.4; 34.2) Year 5 141 48.9% (40.4; 57.5)
Nimenrix mesec 1 356 82,0 % (77,6; 85,9) leto 1 350 29,1 % (24,4; 34,2) leto 5 141 48,9 % (40,4; 57,5)
1 year persistence (study MenACWY-TT-028)
1-letno trajanje (študija MenACWY-TT-028)
Nimenrix is supplied as a white powder or cake in a single dose glass vial and a clear and colourless solvent in a pre-filled syringe.
Cepivo Nimenrix je na voljo kot bel prašek ali pogača v stekleni viali z enkratnim odmerkom in kot bister in brezbarven vehikel v napolnjeni injekcijski brizgi.
Persistence of the immune response was evaluated by rSBA and hSBA up to 5 years in children initially vaccinated in study MenACWY-TT-027 (Table 8).
Trajanje imunskega odziva so ocenili z rSBA in hSBA do 5 let pri otrocih, ki so prejeli začetno cepljenje v študiji MenACWY-TT-027 (preglednica 8).
Table 3: Bactericidal antibody responses (rSBA* and hSBA**) in infants after one dose at 6 months of age and after a booster dose at 15-18 months of age (Study MenACWY-TT-087)
Preglednica 3: Odzivi baktericidnih protiteles (rSBA* in hSBA**) pri dojenčkih po enem odmerku pri 6 mesecih starosti in po obnovitvenem odmerku pri 15-18 mesecih starosti (študija MenACWY-TT-087)
Nimenrix is a powder and a solvent for solution for injection.
Cepivo Nimenrix vsebuje prašek in vehikel za raztopino za injiciranje.
Table 2: Bactericidal antibody responses (rSBA* and hSBA**) in infants after two doses given 2 months apart and after a booster dose at 12 months of age (Study MenACWY-TT-083)
Preglednica 2: Odzivi baktericidnih protiteles (rSBA* in hSBA**) pri dojenčkih po dveh odmerkih, danih v presledku 2 mesecev, in po obnovitvenem odmerku pri 12 mesecih starosti (študija MenACWY-TT-083)
Fainting can occur (mostly in adolescents) following, or even before, any needle injection.
Omedlevica se lahko pojavi po vsakem injiciranju z iglo ali celo pred njim.
Neisseria meningitidis group C polysaccharide1
Polisaharid Neisseria meningitidis skupine C
(1) blood sampling performed 42 to 56 days post vaccination (2) blood sampling performed 30 to 42 days post vaccination * tested at GSK laboratories
odvzem krvi so opravili od 42 do 56 dni po cepljenju odvzem krvi so opravili od 30 do 42 dni po cepljenju * testirano v laboratorijih družbe GSK
From age 1 year and above, Nimenrix can be given concomitantly with any of the following vaccines: hepatitis A (HAV) and hepatitis B (HBV) vaccines, measles - mumps - rubella (MMR) vaccine, measles - mumps - rubella - varicella (MMRV) vaccine, 10-valent pneumococcal conjugate vaccine or unadjuvanted seasonal influenza vaccine.
Od prvega leta starosti naprej se cepivo Nimenrix lahko uporabi hkrati s katerimkoli od naslednjih cepiv: cepiva proti hepatitisu A (HAV) in hepatitisu B (HBV), cepivo proti ošpicam-mumpsu-rdečkam (MMR), cepivo proti ošpicam-mumpsu-rdečkam-noricam (MMRV), 10-valentno konjugirano pnevmokokno cepivo in cepivo proti sezonski gripi brez adjuvansa.
• If you get any side effects, talk to your doctor or pharmacist.
• Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Powder and solvent for solution for injection in a pre-filled syringe
prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi
Meningo coccal Group
Meningo kokna skupina
Table 9: Bactericidal antibody responses (rSBA*) to Nimenrix and the ACWY-PS vaccine in children aged 2-10 years 1 month after vaccination (study MenACWY-TT-038)
Preglednica 9: Odziv baktericidnih protiteles (rSBA*) na cepivi Nimenrix in ACWY-PS pri otrocih, starih od 2 do 10 let, 1 mesec po cepljenju (študija MenACWY-TT-038) Meningokokna skupina
Persistence of the immune response was evaluated by hSBA up to 5 years after vaccination in adolescents and adults initially vaccinated in MenACWY-TT-052 (Table 14) (see section 4.4).
Trajanje imunskega odziva so ocenili s hSBA do 5 let po cepljenju pri mladostnikih in odraslih, ki so prejeli začetno cepljenje v študiji MenACWY-TT-052 (preglednica 14) (glejte poglavje 4.4).
• at least a 4-fold increase in rSBA titres from pre- to post-vaccination for initially seropositive subjects (i.e., pre-vaccination rSBA titre ≥8)
• z vsaj 4-kratnim porastom titrov rSBA od pred cepljenjem do po cepljenju pri uvodoma seropozitivnih preskušancih (tj. titer rSBA pred cepljenjem ≥ 8) * testirano v laboratorijih družbe GSK
MenCCRM vaccine
Nimenrix cepivo MenCCRM
Month 1 334 91.0% (87.4; 93.9) Year 1 327 98.5% (96.5; 99.5) Year 5 138 87.0% (80.2; 92.1)
Nimenrix mesec 1 334 91,0 % (87,4; 93,9) leto 1 327 98,5 % (96,5; 99,5) leto 5 138 87,0 % (80,2; 92,1)
Powder for Nimenrix MenACWY Conjugate IM
prašek za cepivo Nimenrix Konjugat MenACWY i.m.
1conjugated to tetanus toxoid carrier protein
5 mikrogramov konjugiran na nosilno beljakovino tetanusnega toksoida
Month 1 359 96.1% (93.5; 97.9) Year 1 336 94.9% (92.0; 97.0) Year 5 140 92.9% (87.3; 96.5)
Nimenrix mesec 1 359 96,1 % (93,5; 97,9) leto 1 336 94,9 % (92,0; 97,0) leto 5 140 92,9 % (87,3; 96,5)
Persistence of immunogenicity was analysed using the year 5 ATP cohort.
Za analizo trajanja imunogenosti so uporabili kohorto ATP za leto 5.
Meningococcal Group
Meningokokna skupina
Study MenACWY-TT-104(1)
Študija MenACWY-TT-104
10 vials: powder 10 pre-filled syringes: solvent 20 needles
10 napolnjenih injekcijskih brizg: vehikel 20 igel
Although similar responses to groups A and C were observed with both dosing schedules, a single primary dose in infants at 6 months was associated with lower hSBA responses to groups W-135 and Y as measured by the percentage of subjects with hSBA titres ≥8 [87.2% (95% CI: 74.3, 95.2) and 92.3% (95% CI:
Čeprav so pri obeh shemah odmerjanja ugotovili podobne odzive proti skupinama A in C, je bil enkratni osnovni odmerek pri dojenčkih, starih 6 mesecev, povezan z manjšimi odzivi hSBA proti skupinama W-135 in Y, merjeno z odstotkom preskušancev s titri hSBA ≥ 8 [87,2 % (95 % IZ: 74,3; 95,2) oz. 92,3 % (95 % IZ: 81,5; 97,9)], v primerjavi s 3 osnovnimi odmerki pri starosti 2, 4 in 6 mesecev [100 % (95 % IZ: 96,6; 100) oz. 100 % (95 % IZ: 97,1; 100)] (glejte poglavje 4.4).
Nimenrix is not likely to affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi cepivo Nimenrix vplivalo na vašo sposobnost za upravljanje vozil ali strojev.
Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal group A, C, W-135 and Y conjugate vaccine
Nimenrix prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi cepivo proti meningokokom skupin A, C, W-135 in Y, konjugirano
MenCTT vaccine
em odmerku cepivo MenC-TT
Study MenACWY-TT-039(1)
Študija MenACWY-TT-039
The clinical relevance of these observations is unknown.
Klinični pomen teh opažanj ni znan.
Serum bactericidal activity was also measured using hSBA as a secondary endpoint.
Kot sekundarni opazovani dogodek so merili tudi baktericidno delovanje v serumu, in sicer s hSBA.
Very common Fever Swelling at injection site Pain at injection site Redness at injection site Fatigue
Splošne težave in spremembe na mestu aplikacije zelo pogosti zvišana telesna temperatura oteklina na mestu injiciranja bolečina na mestu injiciranja pordelost na mestu injiciranja utrujenost pogosti hematom na mestu injiciranja*
Instructions for reconstitution of the vaccine with the solvent presented in ampoules
Navodila za rekonstitucijo cepiva z vehiklom, priloženim v ampuli
EU/1/12/767/007 - pack of 100
EU/1/12/767/007 - pakiranje po 100
Table 13: 5 years persistence data (rSBA*) in adolescents aged 11-17 years at vaccination Menin gococc al
Preglednica 13: Podatki o trajanju imunskega odziva (rSBA*) 5 let po cepljenju pri mladostnikih, ob cepljenju starih od 11 do 17 let
EU/1/12/767/005 - pack of 1
EU/1/12/767/005 - pakiranje po 1
Infants from 6 weeks to less than 12 months of age: One booster dose at 12 months of age, at least 2 months after the last dose of Nimenrix.
En obnovitveni odmerek pri starosti 12 mesecev, najmanj 2 meseca po zadnjem odmerku cepiva Nimenrix.
Nimenrix powder and solvent for solution for injection in ampoule Meningococcal group A, C, W-135 and Y conjugate vaccine
Nimenrix prašek in vehikel za raztopino za injiciranje v ampuli cepivo proti meningokokom skupin A, C, W-135 in Y, konjugirano
Study MenACWY-TT-040(2)
Študija MenACWY-TT-040
Mening ococcal Group
Mening okokna skupina
Vaccine group rSBA*
Skupina, ki je prejemala cepivo rSBA*
Instructions for reconstitution of the vaccine with the solvent presented in pre-filled syringe:
Navodilo za rekonstitucijo cepiva, pri katerem je vehikel v napolnjeni injekcijski brizgi:
Table 5: Bactericidal antibody responses (hSBA*) in toddlers aged 12-23 months Meningococcal
Preglednica 5: Odziv baktericidnih protiteles (hSBA*) pri malčkih, starih od 12 do 23 mesecev Meningokokna skupina
Very common Irritability Uncommon
Psihiatrične motnje zelo pogosti razdražljivost občasni nespečnost jok
The analysis of immunogenicity was conducted on the primary according-to-protocol (ATP) cohort for immunogenicity.
Analizo imunogenosti so opravili na kohortah ATP (ATP - According-to-Protocol) za imunogenost.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni mialgija bolečina v okončinah
Toddlers aged 12-14 months had similar rSBA responses to groups A, C, W-135 and Y at one month after one dose of Nimenrix or at one month after two doses of Nimenrix given two months apart.
Imunski odzivi pri malčkih, starih od 12 do 14 mesecev Malčki, stari od 12 do 14 mesecev, so imeli en mesec po enem odmerku cepiva Nimenrix ali en mesec po dveh odmerkih cepiva Nimenrix, danih v presledku 2 mesecev, podobne odzive rSBA proti skupinam A, C, W-135 in Y.
EU/1/12/767/006 - pack of 10
EU/1/12/767/006 - pakiranje po 10
Instructions for reconstitution of the vaccine with the solvent presented in pre-filled syringe
Navodila za rekonstitucijo cepiva z vehiklom, priloženim v napolnjeni injekcijski brizgi
100 vials: powder 100 ampoules: solvent 100 x 1 dose (0.5 ml)
100 vial: prašek 100 ampul: vehikel 100 x 1 odmerek (0,5 ml)
1 vial: powder 1 pre-filled syringe: solvent 2 needles
1 napolnjena injekcijska brizga: vehikel 2 igli
How Nimenrix works
Kako deluje cepivo Nimenrix
Previously vaccinated individuals 12 months of age and older: Please tell your doctor if you have received a previous injection with another meningococcal vaccine than Nimenrix.
Obvestite zdravnika, če ste bili predhodno cepljeni z drugim meningokoknim cepivom kot je cepivo Nimenrix.
The analysis of immunogenicity was conducted on ATP cohort for persistence.
Analizo imunogenosti so opravili na kohorti ATP za trajanje.
Table 7: Bactericidal antibody responses (hSBA)* in toddlers aged 12-14 months Meningococcal
Preglednica 7: Odziv baktericidnih protiteles (hSBA*) pri malčkih, starih od 12 do 14 mesecev Meningokokna skupina
The analysis of immunogenicity was conducted on the according-to-protocol (ATP) cohort for immunogenicity (1) blood sampling performed 21-48 days post vaccination * tested at Public Health England laboratories
odvzem krvi so opravili od 21 do 48 dni po cepljenju * testirano v laboratorijih PHE (Public Health England)
The analysis of immunogenicity was conducted on ATP cohort for immunogenicity.
Analizo imunogenosti so opravili na kohorti ATP za imunogenost.
1 vial: powder 1 ampoule: solvent 1 dose (0.5 ml)
1 viala: prašek 1 ampula: vehikel 1 odmerek (0,5 ml)
Neisseria meningitidis group Y polysaccharide1
Polisaharid Neisseria meningitidis skupine Y
Check with your doctor or nurse before you receive this vaccine if:
Preden prejmete to cepivo, se posvetujte z zdravnikom ali medicinsko sestro:
10 vials: powder 10 ampoules: solvent 10 x 1 dose (0.5 ml)
10 vial: prašek 10 ampul: vehikel 10 x 1 odmerek (0,5 ml)
How to store Nimenrix
Kako se daje cepivo Nimenrix
Persistence of the immune response was evaluated in children initially vaccinated in MenACWY-TT081 (Table10).
Trajanje imunskega odziva so ocenili z rSBA in hSBA pri otrocih, ki so prejeli začetno cepljenje v študiji MenACWY-TT-081 (preglednica 10).
The clinical relevance of the findings is unknown.
Klinični pomen teh ugotovitev ni znan.
MenC-CRM
cepivo MenC-CRM 121
Table 4: Bactericidal antibody responses (rSBA*) in toddlers aged 12-23 months Menin gococc al
Preglednica 4: Odziv baktericidnih protiteles (rSBA*) pri malčkih, starih od 12 do 23 mesecev Meningokokna skupina
Intramuscular use.
NAPOLNJENA INJEKCIJSKA BRIZGA Z VEHIKLOM
The clinical relevance of this finding is unknown.
Klinični pomen tega izsledka ni znan.
Syringe cap
Pokrovček brizge
VR: vaccine response * tested at GSK laboratories Persistence of the immune response was evaluated up to 5 years after vaccination in adolescents primed in study MenACWY-TT-036 (Table 13).
Trajanje imunskega odziva so ocenili do 5 let po cepljenju pri mladostnikih, ki so prejeli osnovno cepljenje v študiji MenACWY-TT-036 (preglednica 13).
Nimenrix is a vaccine which helps protect against infections caused by bacteria (germs) called “Neisseria meningitidis" types A, C, W-135 and Y. “Neisseria meningitidis" types A, C, W-135 and Y bacteria can cause serious illnesses such as:
Bakterije “Neisseria meningitidis" tipov A, C, W-135 in Y lahko povzročijo resne bolezni, na primer:
N ≥8 (95% CI)
Časovna točka n  8 (95 % IZ)
W-135 Nimenrix 354 100% Y Nimenrix 354 100%
W-135 Nimenrix 1 odmerek po 1. odmerku
Timepoint
Časovni okvir
Adverse reactions
Obnovitveni odmerki
The analysis of immunogenicity was conducted on the according-to-protocol (ATP) cohort for immunogenicity (1) blood sampling performed 21-48 days post vaccination *tested at GSK laboratories
odvzem krvi so opravili od 21 do 48 dni po cepljenju * testirano v laboratorijih družbe GSK
Nimenrix MenCCRM vaccine W-135 Nimenrix
Shranjevanje cepiva Nimenrix
Table 6: Bactericidal antibody responses (rSBA)* in toddlers aged 12-14 months Meningococcal
Preglednica 6: Odziv baktericidnih protiteles (rSBA*) pri malčkih, starih od 12 do 14 mesecev
1 year CSR Q1 2017 3 year CSR Q1 2019 5 year CSR Q1 2021
Poročilo o klinični študiji za 3. leto - 1. četrtletje 2019
1 vial: powder 1 pre-filled syringe: solvent 1 dose (0.5 ml)
1 napolnjena injekcijska brizga: vehikel 1 odmerek (0,5 ml)
• itching
• jok
Nimenrix 2 doses
Nimenrix 2 odmerka po 1. odmerku po 2. odmerku
10 vials: powder 10 pre-filled syringes: solvent 10 x 1 dose (0.5 ml)
10 napolnjenih injekcijskih brizg: vehikel 10 x 1 odmerek (0,5 ml)
Very common Drowsiness Headache
Bolezni živčevja zelo pogosti zaspanost glavobol občasni hipestezija omotica
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE WITH SOLVENT
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH MEN ACWY CONJUGATE POWDER
VIALA S PRAŠKOM KONJUGATA MEN ACWY
Y 657 93.8%
leto 1 356 97,8 % (95,6; 99,0)
• Keep this medicine out of the sight and reach of children.
• Cepivo shranjujte nedosegljivo otrokom!
• crying
• utrujenost
Post dose Post dose
po 2. odmerku po obnovitven
Imatinib Actavis is available as capsules (50, 100 and 400 mg) and tablets (100 and 400 mg).
Zdravilo Imatinib Actavis je na voljo v obliki kapsul (50, 100 in 400 mg) in tablet (100 in 400 mg).
It is also used in children in the ‘chronic phase' of the disease if it is not responding to interferon alfa (another medicine used to treat cancer), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis').
Uporablja se tudi pri otrocih v kronični fazi bolezni, če se ta ne odziva na interferon alfa (drugo zdravilo za zdravljenje raka), ter v napredovalih fazah bolezni (pospešeni fazi in blastni krizi).