natgillin/translations-raw huggingface dataset:
Intramuscular injection.
intramuskularna injekcija
- have haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants).
- imate hemofilijo ali druge težave, zaradi katerih se kri ne strjuje pravilno, na primer osebe, ki prejemajo zdravila za redčenje krvi (antikoagulante).
As with other vaccines, Menveo should be postponed in individuals suffering from an acute severe febrile illness.
Kot pri vseh drugih cepivih je treba tudi cepljenje s cepivom Menveo odložiti pri posameznikih, ki imajo akutno hudo vročinsko bolezen.
Common: eating disorder
Pogosti: motnje prehranjevanja
This vaccine contains a protein (called CRM197) from the bacteria that cause diphtheria.
Cepivo vsebuje beljakovino (imenovano CRM197) iz bakterije, ki povzroča davico.
Immunogenicity was evaluated in randomised, multicenter, active controlled clinical trials that enrolled children (2-10 years of age), adolescents (11-18 years of age), adults (19-55 years of age) and older adults (56-65 years of age).
Imunogenost so ocenili v randomiziranih, multicentričnih, aktivno kontroliranih kliničnih preskušanjih, v katera so vključili otroke (2-10 let starosti), mladostnike (11-18 let starosti), odrasle (19-55 let starosti) in starejše (56-65 let starosti).
What Menveo is and what it is used for What you need to know before you or your child are given Menveo How to use Menveo
Kaj je cepivo Menveo in za kaj ga uporabljamo Kaj morate vedeti, preden se s cepivom Menveo cepite vi ali vaš otrok Kako uporabljati cepivo Menveo
Please note that it is normal for a small amount of liquid to remain in the vial following withdrawal of the dose.
Običajno je, da ostane majhna količina tekočine po izvleku celotnega odmerka v viali.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
This means that you (or your child) should receive other vaccines to protect against diphtheria when these are due or when advised by your doctor.
To pomeni, da morate vi ali vaš otrok za zaščito pred davico prejeti drugo cepivo, kadar je cepljenje v načrtu oziroma ga priporoči zdravnik.
The clinical benefit of a 2-dose vaccination series in children 2 through 10 years of age is not known.
Klinične koristi serije cepljenja z dvema odmerkoma pri otrocih med 2. in 10. letom starosti niso znane.
A total of 199 subjects 2-5 years of age were in the Menveo per protocol immunogenicity population and 81 subjects 3-5 years of age were in the ACWY-PS group.
Skupaj 199 oseb, starih 2-5 let, je bilo v skupini s cepivom Menveo po protokolu populacije imunogenosti in 81 oseb, starih 3-5 let, je bilo v skupini ACWY-PS.
There was evidence of some suppression of antibody response to two of the three pertussis antigens.
Opazili so znake določene supresije odziva protiteles na dva od treh antigenov oslovskega kašlja.
GMTs declined over time as expected but remained between 2- and 8-fold higher than prebooster values (Table 8).
Vrednosti GMT so se sčasoma znižale, vendar so ostale med 2- in 8-krat višje kot vrednosti pred poživitvenim odmerkom (tabela 8).
Serum bactericidal activity (SBA) was measured using human serum as the source of exogenous complement (hSBA).
Serumsko baktericidno aktivnost (SBA) so izmerili s humanim serumom kot virom eksogenega komplementa (hSBA).
As with any vaccine, Menveo may not fully protect 100% of those who get the vaccine.
Kot pri vseh cepivih tudi cepivo Menveo morda ne nudi 100-odstotne zaščite vsem cepljenim osebam.
Common: arthralgia
Pogosti: artralgija
V59P6E1 (5 years post vaccination)
V59P6E1 (5 let po cepljenju)
In laboratory animals, no adverse reactions were seen in vaccinated maternal rabbits or in their offspring through postnatal day 29.
V študijah na laboratorijskih živalih niso opazili neželenih učinkov pri cepljenih samicah kuncev ali njihovih potomcih do 29. dne po skotitvi.
The efficacy of Menveo has been inferred by measuring the production of serogroup-specific anti-capsular antibodies with bactericidal activity.
Učinkovitost cepiva Menveo je bila ugotovljena z merjenjem nastajanja za seroskupino specifičnih antikapsularnih protiteles z baktericidno aktivnostjo.
MARKETING AUTHORISATION NUMBER(S) EU/1/10/614/003 - 1 dose pack EU/1/10/614/002 - 5 doses pack
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/614/003 - pakiranje z 1 odmerkom EU/1/10/614/002 - pakiranje s 5 odmerki
The children also received a booster dose of Menveo, 5 years after a single dose primary vaccination.
Otroci so prejeli tudi poživitveni odmerek cepiva Menveo 5 let po enem odmerku osnovnega cepljenja.
One dose (0.5 ml of the reconstituted vaccine) contains: The active substances are: (Originally contained in the powder)
En odmerek (0,5 ml rekonstituiranega cepiva) vsebuje: (Originalno vsebovano v prašku)
In adolescents (from 11 years of age) and adults, the most common side effects that were reported during clinical trials are listed below.
Pri mladostnikih (starih več kot 11 let) in odraslih so najpogostejši neželeni učinki, o katerih so poročali v kliničnih preskušanjih, našteti spodaj.
The safety and efficacy of Menveo in children under 2 years of age has not yet been established.
Varnost in učinkovitost cepiva Menveo pri otrocih, mlajših od 2 let, še nista bili dokazani.
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 ºC - 8 ºC).
Your doctor will advise you if and when you should receive a booster dose.
Zdravnik vam bo svetoval, če morate prejeti poživitveni odmerek, in kdaj.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or diphtheria toxoid (CRM197), or a life-threatening reaction after previous administration of a vaccine containing similar components (see section 4.4).
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, toksoid davice (CRM197) ali življenjsko ogrožajoča reakcija po predhodnem apliciranju cepiva s podobnimi sestavinami (glejte poglavje 4.4).
Neisseria meningitidis serogroup A, C, W-135 and Y bacteria can cause serious and sometimes life-threatening infections such as meningitis and sepsis (blood poisoning).
Bakterija Neisseria meningitidis seroskupin A, C, W-135 in Y lahko povzroči hude in včasih življenjsko nevarne okužbe, kot sta meningitis in sepsa (zastrupitev krvi).
V59P13E1 (3 years post vaccination)
V59P13E1 (3 leta po cepljenju)
The administration of Menveo one month after Tdap resulted in statistically significantly lower serogroup W-135 seroresponses.
Apliciranje cepiva Menveo en mesec po Tdap je povzročilo statistično značilno nižje seroodzive seroskupine W-135.
Powder in vial (type I glass) with a stopper (butyl rubber with fluoropolymer coated surface) and solution in vial (type I glass) with a stopper (butyl rubber).
Prašek v viali (steklo tipa I) z zamaškom (butilna guma prekrita s fluoropolimerom) in raztopina v viali (steklo tipa I) z zamaškom (butilna guma).
Immunogenicity in individuals 11 years of age and above
Imunogenost pri osebah, starih 11 in več let
2-5 years
2-5 let
Menveo may be given at the same time as other vaccinations but any other injected vaccines should preferably be given into a different arm from the site of the Menveo injection.
Cepivo Menveo se lahko daje sočasno z drugimi cepivi, vendar je treba katero koli drugo cepivo injicirati po možnosti v drugo roko kot je mesto injiciranja cepiva Menveo.
Little is known about the effectiveness of Menveo when administered to individuals with weakened immunity due to the use of immunosuppressive medications, or HIV infection, and other possible causes.
O učinkovitosti cepiva Menveo, danega posameznikom z oslabljenih imunskim sistemom zaradi uporabe imunosupresivov ali okužbe z virusom HIV ter zaradi drugih možnih vzrokov, ni veliko znanega.
Considering the severity of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y, pregnancy should not preclude vaccination when the risk of exposure is clearly defined.
Ob upoštevanju resnosti invazivne meningokokne bolezni, ki jo povzroča Neisseria meningitidis seroskupin A, C, W-135 in Y, nosečnost ne sme biti razlog za zadržanje cepljenja, ko je tveganje izpostavljenosti jasno prisotno.
Other medicines and Menveo
Druga zdravila in cepivo Menveo
If a vaccine recipient is undergoing immunosuppressant treatment, the immunological response may be diminished.
Če prejema oseba, ki se cepi, imunosupresivno terapijo, bo morda imunološki odziv manjši.
Immunogenicity in older adults
Imunogenost pri starejših odraslih
The characterization of the safety profile of Menveo in adolescents and adults is based on data from five randomised controlled clinical trials including 6401 participants (from 11-65 years of age) who received Menveo.
Osebe, stare 11 do 65 let Opredelitev varnostnega profila cepiva Menveo pri mladostnikih in odraslih temelji na podatkih petih randomiziranih kontroliranih kliničnih preskušanjih s 6.401 udeleženci (starimi od 11 do 65 let), ki so prejeli cepivo Menveo.
Using a syringe and suitable needle (21G, 40 mm length or 21 G, 1 ½ inch length), withdraw the entire contents of the vial of solution and inject into the vial of powder to reconstitute the MenA conjugate component.
Z brizgo in ustrezno iglo (velikost 21 G, 40 mm ali 21 G, 1 ½ ") izvlecite celotno vsebino viale z raztopino in jo injicirajte v vialo s praškom, da rekonstituirate komponento konjugata MenA.
6.6 Special precautions for disposal and other handling Menveo must be prepared for administration by reconstituting powder (in vial) with solution (in vial).
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Cepivo Menveo je treba pred uporabo pripraviti z rekonstitucijo praška (v viali) z raztopino (v viali).
Menveo should under no circumstances be administered intravascularly.
Cepiva Menveo se v nobenem primeru ne sme dati intravaskularno.
Ensure that no air bubbles are present in the syringe before injecting the vaccine.
V brizgi ne sme biti pred injiciranjem cepiva nobenih zračnih mehurčkov.
In immunocompromised individuals, vaccination may not result in an appropriate protective antibody response.
Pri osebah z oslabljenim imunskim sistemom morda cepljenje ne bo izzvalo ustreznega zaščitnega protitelesnega odziva.
Following reconstitution, the vaccine is a clear, colourless to light yellow solution, free from visible foreign particles.
Po rekonstituciji je cepivo bistra, brezbarvna do rahlo rumenkasta raztopina brez vidnih delcev.
The immunogenicity of Menveo in children 2 to 23 months of age was evaluated in several studies.
Razpoložljivi podatki pri otrocih, starih 2 do 23 mesecev Imunogenost cepiva Menveo pri otrocih, starih od 2 do 23 mesecev so ovrednotili v več študijah.
One dose consists of 1 vial of MenA Lyophilised Conjugate Component to be reconstituted with 1 vial of MenCWY Liquid Conjugate Component.
En odmerek je sestavljen iz 1 viale komponente liofiliziranega konjugata MenA, ki se ga rekonstituira z 1 vialo komponente tekočega konjugata MenCWY.
It should be checked if the adverse reactions may be intensified by any co-administration.
Preveriti je treba, ali sočasno apliciranje morda okrepi neželene učinke.
Insufficient clinical data on exposed pregnancies are available.
Na voljo ni zadostnih kliničnih podatkov o uporabi cepiva Menveo pri nosečnicah.
In the pivotal study V59P20 immunogenicity of Menveo was compared to ACWY-D; 1170 children were vaccinated with Menveo and 1161 received the comparator vaccine in the per protocol populations.
V osrednji študiji V59P20 so imunogenost cepiva Menveo primerjali z ACWY-D; 1.170 otrok so cepili s cepivom Menveo in 1.161 jih je prejelo primerjalno cepivo v populaciji po protokolu.
Pack size of one dose (2 vials) or five doses (10 vials).
Velikost pakiranja je en odmerek (2 viali) ali pet odmerkov (10 vial).
Please tell your doctor if you have received a previous injection with Menveo or another meningococcal vaccine.
Obvestite zdravnika, če ste že bili cepljeni s cepivom Menveo ali drugim meningokoknim cepivom.
Sera were obtained both before vaccination and 1 month after vaccination.
Serum so pridobili pred cepljenjem in 1 mesec po njem.
Concomitant administration of Menveo and other vaccines than those listed above has not been studied.
Sočasnega apliciranja cepiva Menveo z drugimi cepivi, ki niso našteta zgoraj, niso preučili.
(Originally contained in the solution) • Meningococcal group C oligosaccharide
(Originalno vsebovano v raztopini) • Oligosaharid meningokoka skupine C
Menveo may be given as a booster dose in subjects who have previously received primary vaccination with Menveo, other conjugated meningococcal vaccine or meningococcal unconjugated polysaccharide vaccine.
Cepivo Menveo se lahko daje v obliki poživitvenega odmerka osebam, ki so pred tem prejele osnovno cepljenje s cepivom Menveo, drugim konjugiranim meningokoknim cepivom ali nekonjugiranim meningokoknim polisaharidnim cepivom.
After reconstitution, the medicinal product should be used immediately.
Rekonstituirano cepivo je treba uporabiti takoj.
(≥1/10,000 to <1/1,000)
(≥1/10.000 do <1/1.000)
Do not use this medicine after the expiry date which is stated on the outer carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Menveo has not been evaluated in persons with thrombocytopenia, bleeding disorders or that are receiving anticoagulant therapy, because of the risk of haematoma.
Cepiva Menveo niso ocenili pri osebah s trombocitopenijo, motnjami krvavitev in pri osebah, ki prejemajo zdravila proti strjevanju krvi, saj obstaja tveganje hematoma.
Immunogenicity in adolescents
Imunogenost pri mladostnikih
In the pivotal immunogenicity trial, V59P13, immune responses to Menveo were assessed among adults aged 19 to 55 years.
V osrednjem preskušanju imunogenosti, V59P13, so bili imunski odzivi na cepivo Menveo ocenjeni med odraslimi, starimi 19 do 55 let.
Five doses (10 vials) per package.
Pet odmerkov (10 vial) na pakiranje.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
To cepivo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ”brez natrija”.
This medicinal products contains less than 1 mmol potassium (39 mg) per dose, i.e. essentially ‘potassium-free'.
To cepivo vsebuje manj kot 1 mmol (39 mg) kalija na odmerek, kar v bistvu pomeni ”brez kalija”.
Marketing Authorisation Holder: GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italy
Imetnik dovoljenja za promet: GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italija
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).
Cepivo Menveo se lahko daje sočasno s katerim koli od naslednjih cepiv: monovalentno ali kombinirano cepivo proti hepatitisu A in B, rumeni mrzlici, tifusni vročici (polisaharid Vi), japonskem encefalitisu, steklini in meningokokom skupine B (cepivo Bexsero).
Menveo will not protect against infections caused by any other serogroups of N. meningitidis not present in the vaccine.
Cepivo Menveo ne ščiti pred okužbami, ki jih povzročajo druge seroskupine bakterije N. meningitidis,
Immunogenicity in children 2 to 10 years of age
Imunogenost pri otrocih, starih 2 do 10 let
Menveo's effect could be diminished when administered to individuals who are taking medicines that suppress the immune system.
Učinki cepiva Menveo lahko oslabijo, če se cepijo osebe, ki jemljejo zdravila za zaviranje odziva imunskega sistema.
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).
Za zagotavljanje optimalne koncentracije protiteles proti vsem seroskupinam cepiva je treba osnovno shemo cepljenja s cepivom Menveo zaključiti en mesec prej, preden se pojavi tveganje izpostavitve bakteriji Neisseria meningitidis skupin A, C, W-135 in Y. Baktericidna protitelesa (hSBA ≥ 1 : 8) so opazili pri najmanj 64 % oseb en teden po cepljenju (glejte poglavje 5.1 za podatke o imunogenosti pri posamezni seroskupini).
There are no data on the applicability of the vaccine for post-exposure prophylaxis.
Ni podatkov o primernosti cepiva za zaščito po izpostavitvi.
Uncommon (may affect up to 1 in 100 people): injection site itching
Občasni (pojavijo se lahko pri največ 1 do 100 cepljenih oseb): srbenje na mestu injiciranja
Although a high percentage of subjects achieved hSBA titres above 1:8 following 4-dose series of Menveo, with lower percentages in studies of 2-dose series and of a single dose, Menveo was compared to another meningococcal vaccine in only one pivotal study, where it failed to show a response at least equivalent to a monovalent conjugated serotype C vaccine (after a single dose at the age of 12 months).
Kljub velikemu odstotku preiskovancev, ki so imeli po shemi s 4 odmerki titre hSBA nad 1:8, in nižjemu odstotku v študijah sheme z 2 odmerkoma in 1 odmerkom, so cepivo Menveo primerjali z drugim meningokoknim cepivom v samo eni ključni študiji, v kateri ni spodbudil vsaj enakovrednega odziva kot monovalentno konjugirano cepivo proti serotipu C (po enem odmerku v starosti 12 mesecev).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italy
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italija
Menveo is a powder and a solution for injection.
Cepivo Menveo je prašek in raztopina za injiciranje.
What Menveo looks like and contents of the pack
Izgled cepiva Menveo in vsebina pakiranja
No studies on the effects on the ability to drive and use machines have been performed.
Vpliv na sposobnost upravljanja vozil in strojev Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
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).
Študije s cepivom Menveo so pokazale pojemanje titra baktericidnih protiteles v serumu proti seroskupini A pri uporabi testa za določanje baktericidnosti s humanim komplementom (hSBA) (glejte poglavje 5.1).
hSBA GMTs
GMT hSBA
Not known: tonic convulsion, febrile convulsion, syncope Ear and labyrinth disorders
Neznana pogostnost: tonične konvulzije, febrilne konvulzije, sinkopa Ušesne bolezni, vključno z motnjami labirinta
MARKETING AUTHORISATION HOLDER GSK Vaccines S.r.l.
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM GSK Vaccines S.r.l.
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.
Pri otrocih, starih 2-10 let, kot tudi v vseh starostnih podskupinah (2-5 in 6-10 let), so imunski odziv merili v odstotkih oseb s seroodzivom, hSBA ≥ 1:8 in GMT niso bili inferiorni od primerljivega cepiva ACWY-PS, temveč so bili vsi statistično višji od primerjalnega cepiva za vse seroskupine in vsa merjenja imunosti 1 mesec po cepljenju.
The contents of the two components (vial and vial) are to be mixed prior to vaccination providing 1 dose of 0.5 ml.
Vsebini obeh komponent (viala in viala) se pred cepljenjem premešata in tvorita 1 odmerek z 0,5 ml.
In adolescents (11 to 18 years of age), Menveo has been evaluated in two co-administration studies with either Tetanus, Reduced Diphtheria and Acellular Pertussis Vaccine, Adsorbed (Tdap) alone or Tdap and Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant (HPV), both of which support the co-administration of the vaccines.
Pri mladostnikih (starih 11 do 18 let) je bilo cepivo Menveo ovrednoteno v dveh študijah s sočasnim apliciranjem bodisi samo cepiva proti tetanusu, davici (z zmanjšano vsebnostjo antigenov) in oslovskemu kašlju (acelularno, adsorbirano) (Tdap) bodisi cepiva Tdap in štirivalentnega rekombinantnega cepiva proti humanemu virusu papiloma (tipi 6, 11, 16 in 18) (HPV).
In a randomized, observer-blind study (V59_57) conducted in US, immunogenicity of a 2-dose series and a single dose of Menveo was compared in children 2 through 5 and 6 through 10 years of age (N=715).
V randomizirani slepi študiji (V59_57), izvedeni v ZDA, so primerjali imunogenost serije dveh odmerkov in enkratnega odmerka zdravila Menveo pri otrocih med 2. in 5. letom ter med 6. in 10. letom starosti (n = 715).
The most common side effects reported during clinical trials usually lasted only one to two days and were not usually severe.
Najpogostejši neželeni učinki, o katerih so poročali med kliničnimi preskušanji, so običajno trajali samo en dan ali dva dni in običajno niso bili hudi.
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.
Od tistih, ki so prejeli cepivo Menveo, jih je bilo 58,9 % starih 11-18 let, 16,4 % je bilo starih 19-34 let, 21,3 % je bilo starih 35-55 let in 3,4 % je bilo starih 56-65 let.
One dose (2 vials) per package.
En odmerek (2 viali) na pakiranje.
The onset of immune response after the primary vaccination with Menveo in healthy subjects 18 through 22 years of age was evaluated in study V59P6E1.
Nastanek imunskega odziva po osnovnem cepljenju s cepivom Menveo pri zdravih osebah, starih med 18 in 22 let, so preučevali v študiji V59P6E1.
In two supportive studies V59P8 and V59P10 immunogenicity of Menveo was compared to ACWY-PS.
V dveh podpornih študijah, V59P8 in V59P10, so imunogenost cepiva Menveo primerjali z ACWY-PS.
Individuals with familial complement deficiencies (for example, C3 or C5 deficiencies) and individuals receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis group A, C, W-135 and Y, even if they develop antibodies following vaccination with Menveo.
Posamezniki, ki imajo pomanjkanje komplementa (na primer pomanjkanje C3 ali C5) v družini in posamezniki, zdravljeni z zdravili, ki zavirajo aktivacijo terminalnega komplementa (na primer ekulizumab), imajo večje tveganje za invazivne bolezni, ki jih povzroča Neisseria meningitidis skupin A, C, W-135 in Y, čeprav razvijejo protitelesa po cepljenju s cepivom Menveo.
Children 2 to 10 years of age
Otroci, stari 2 do 10 let
As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic event following administration of the vaccine.
Tako kot pri vseh cepivih, ki se injicirajo, je treba zagotoviti ustrezno obliko zdravljenja in zdravniškega nadzora, ki morata biti v primeru anafilaktične reakcije na cepljenje nemudoma na voljo.
Individuals with complement deficiencies and individuals with functional or anatomical asplenia may not mount an immune response to meningococcal group A, C, W-135 and Y conjugate vaccines.
Posamezniki s pomanjkljivostmi komplementa in posamezniki s funkcijsko ali anatomsko asplenijo morda ne bodo dosegli imunskega odziva na konjugirana cepiva proti meningokokom skupin A, C, W-135 in Y.
For instructions on preparation and reconstitution of the medicinal product before administration, see section 6.6.
Za navodila glede priprave in rekonstitucije cepiva pred dajanjem glejte poglavje 6.6. 4.3 Kontraindikacije