FrancophonIA/ELRC3.0 huggingface dataset:
English: In the adolescent age group, the safety and tolerability of the vaccine was favourable relative to Tdap and did not substantially change with concomitant or sequential administration of other vaccines.
Slovenian: V starostni skupini mladostnikov sta bila varnost in prenašanje cepiva boljša kot pri Tdap in se nista bistveno spremenila s sočasnim ali zaporednim apliciranjem drugih cepiv.
English: The clinical relevance of this observation is unknown.
Slovenian: Klinična pomembnost tega izsledka ni znana.
English: Read all of this leaflet carefully before you or your child are given this medicine because it contains important information for you.
Slovenian: Preden se s tem cepivom cepite vi ali vaš otrok, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: After vaccination, over 97% of subjects had detectable pertussis titers to all three pertussis antigens.
Slovenian: Po cepljenju je imelo več kot 97 % oseb zaznavne titre protiteles proti vsem trem antigenom povzročitelja oslovskega kašlja.
English: Invert and shake the vial vigorously and then withdraw 0.5 ml of reconstituted product.
Slovenian: Vialo obrnite in močno pretresajte, nato pa izvlecite 0,5 ml rekonstituiranega zdravila v brizgo.
English: Menveo is given as an intramuscular injection, preferably into the deltoid muscle.
Slovenian: Cepivo Menveo se daje v obliki intramuskularne injekcije, po možnosti v deltoidno mišico.
English: Therefore, Menveo may be used during breast feeding.
Slovenian: Cepivo Menveo se lahko uporablja med dojenjem.
English: After reconstitution 0.5 ml dose contains:
Slovenian: Po rekonstituciji vsebuje 0,5-mililitrski odmerek:
English: If you or your child received a dose of Menveo more than one year ago and remains at particular risk of exposure to meningococcal group A bacteria, consideration may be given to administering a booster dose to maintain protection.
Slovenian: Če ste vi ali vaš otrok prejeli odmerek cepiva Menveo pred več kot enim letom, in še vedno obstaja veliko tveganje izpostavljenosti bakteriji meningokoka skupine A, je treba razmisliti o dajanju poživitvenega odmerka za ohranitev zaščite.
English: MARKETING AUTHORISATION NUMBERS EU/1/10/614/002
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/10/614/002
English: The clinical relevance of higher post-vaccination immune responses is not known.
Slovenian: Klinični pomen višjega imunskega odziva po cepljenju ni znan.
English: The vaccine is usually given into the upper arm muscle (deltoid) for children (from 2 years of age), adolescents and adults.
Slovenian: Običajno mesto cepljenja je nadlahtna mišica (deltoidna) za otroke (od 2 let starosti), mladostnike in odrasle.
English: Not for intravascular, subcutaneous or intradermal injection.
Slovenian: Ni za intravaskularno, subkutano ali intradermalno injiciranje.
English: Intramuscular injection.
Slovenian: intramuskularna injekcija
English: - have haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants).
Slovenian: - imate hemofilijo ali druge težave, zaradi katerih se kri ne strjuje pravilno, na primer osebe, ki prejemajo zdravila za redčenje krvi (antikoagulante).
English: As with other vaccines, Menveo should be postponed in individuals suffering from an acute severe febrile illness.
Slovenian: Kot pri vseh drugih cepivih je treba tudi cepljenje s cepivom Menveo odložiti pri posameznikih, ki imajo akutno hudo vročinsko bolezen.
English: Common: eating disorder
Slovenian: Pogosti: motnje prehranjevanja
English: This vaccine contains a protein (called CRM197) from the bacteria that cause diphtheria.
Slovenian: Cepivo vsebuje beljakovino (imenovano CRM197) iz bakterije, ki povzroča davico.
English: 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).
Slovenian: 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).
English: 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
Slovenian: 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
English: Please note that it is normal for a small amount of liquid to remain in the vial following withdrawal of the dose.
Slovenian: Običajno je, da ostane majhna količina tekočine po izvleku celotnega odmerka v viali.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
English: 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.
Slovenian: To pomeni, da morate vi ali vaš otrok za zaščito pred davico prejeti drugo cepivo, kadar je cepljenje v načrtu oziroma ga priporoči zdravnik.
English: The clinical benefit of a 2-dose vaccination series in children 2 through 10 years of age is not known.
Slovenian: Klinične koristi serije cepljenja z dvema odmerkoma pri otrocih med 2. in 10. letom starosti niso znane.
English: 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.
Slovenian: 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.
English: There was evidence of some suppression of antibody response to two of the three pertussis antigens.
Slovenian: Opazili so znake določene supresije odziva protiteles na dva od treh antigenov oslovskega kašlja.
English: GMTs declined over time as expected but remained between 2- and 8-fold higher than prebooster values (Table 8).
Slovenian: Vrednosti GMT so se sčasoma znižale, vendar so ostale med 2- in 8-krat višje kot vrednosti pred poživitvenim odmerkom (tabela 8).
English: Serum bactericidal activity (SBA) was measured using human serum as the source of exogenous complement (hSBA).
Slovenian: Serumsko baktericidno aktivnost (SBA) so izmerili s humanim serumom kot virom eksogenega komplementa (hSBA).
English: As with any vaccine, Menveo may not fully protect 100% of those who get the vaccine.
Slovenian: Kot pri vseh cepivih tudi cepivo Menveo morda ne nudi 100-odstotne zaščite vsem cepljenim osebam.
English: Common: arthralgia
Slovenian: Pogosti: artralgija
English: V59P6E1 (5 years post vaccination)
Slovenian: V59P6E1 (5 let po cepljenju)
English: In laboratory animals, no adverse reactions were seen in vaccinated maternal rabbits or in their offspring through postnatal day 29.
Slovenian: V študijah na laboratorijskih živalih niso opazili neželenih učinkov pri cepljenih samicah kuncev ali njihovih potomcih do 29. dne po skotitvi.
English: The efficacy of Menveo has been inferred by measuring the production of serogroup-specific anti-capsular antibodies with bactericidal activity.
Slovenian: Učinkovitost cepiva Menveo je bila ugotovljena z merjenjem nastajanja za seroskupino specifičnih antikapsularnih protiteles z baktericidno aktivnostjo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/614/003 - 1 dose pack EU/1/10/614/002 - 5 doses pack
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/614/003 - pakiranje z 1 odmerkom EU/1/10/614/002 - pakiranje s 5 odmerki
English: The children also received a booster dose of Menveo, 5 years after a single dose primary vaccination.
Slovenian: Otroci so prejeli tudi poživitveni odmerek cepiva Menveo 5 let po enem odmerku osnovnega cepljenja.
English: GSK Vaccines S.r.l., Bellaria-Rosia, 53018 Sovicille (Siena), Italy
Slovenian: GSK Vaccines S.r.l., Bellaria-Rosia, 53018 Sovicille (Siena), Italija
English: One dose (0.5 ml of the reconstituted vaccine) contains: The active substances are: (Originally contained in the powder)
Slovenian: En odmerek (0,5 ml rekonstituiranega cepiva) vsebuje: (Originalno vsebovano v prašku)
English: In adolescents (from 11 years of age) and adults, the most common side effects that were reported during clinical trials are listed below.
Slovenian: Pri mladostnikih (starih več kot 11 let) in odraslih so najpogostejši neželeni učinki, o katerih so poročali v kliničnih preskušanjih, našteti spodaj.
English: The safety and efficacy of Menveo in children under 2 years of age has not yet been established.
Slovenian: Varnost in učinkovitost cepiva Menveo pri otrocih, mlajših od 2 let, še nista bili dokazani.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 ºC - 8 ºC).
English: Your doctor will advise you if and when you should receive a booster dose.
Slovenian: Zdravnik vam bo svetoval, če morate prejeti poživitveni odmerek, in kdaj.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: V59P13E1 (3 years post vaccination)
Slovenian: V59P13E1 (3 leta po cepljenju)
English: The administration of Menveo one month after Tdap resulted in statistically significantly lower serogroup W-135 seroresponses.
Slovenian: Apliciranje cepiva Menveo en mesec po Tdap je povzročilo statistično značilno nižje seroodzive seroskupine W-135.
English: 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).
Slovenian: Prašek v viali (steklo tipa I) z zamaškom (butilna guma prekrita s fluoropolimerom) in raztopina v viali (steklo tipa I) z zamaškom (butilna guma).
English: Immunogenicity in individuals 11 years of age and above
Slovenian: Imunogenost pri osebah, starih 11 in več let
English: 2-5 years
Slovenian: 2-5 let
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Other medicines and Menveo
Slovenian: Druga zdravila in cepivo Menveo
English: If a vaccine recipient is undergoing immunosuppressant treatment, the immunological response may be diminished.
Slovenian: Če prejema oseba, ki se cepi, imunosupresivno terapijo, bo morda imunološki odziv manjši.
English: Immunogenicity in older adults
Slovenian: Imunogenost pri starejših odraslih
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 6.6 Special precautions for disposal and other handling Menveo must be prepared for administration by reconstituting powder (in vial) with solution (in vial).
Slovenian: 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).
English: Menveo should under no circumstances be administered intravascularly.
Slovenian: Cepiva Menveo se v nobenem primeru ne sme dati intravaskularno.
English: Ensure that no air bubbles are present in the syringe before injecting the vaccine.
Slovenian: V brizgi ne sme biti pred injiciranjem cepiva nobenih zračnih mehurčkov.
English: In immunocompromised individuals, vaccination may not result in an appropriate protective antibody response.
Slovenian: Pri osebah z oslabljenim imunskim sistemom morda cepljenje ne bo izzvalo ustreznega zaščitnega protitelesnega odziva.
English: Following reconstitution, the vaccine is a clear, colourless to light yellow solution, free from visible foreign particles.
Slovenian: Po rekonstituciji je cepivo bistra, brezbarvna do rahlo rumenkasta raztopina brez vidnih delcev.
English: The immunogenicity of Menveo in children 2 to 23 months of age was evaluated in several studies.
Slovenian: 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.
English: One dose consists of 1 vial of MenA Lyophilised Conjugate Component to be reconstituted with 1 vial of MenCWY Liquid Conjugate Component.
Slovenian: En odmerek je sestavljen iz 1 viale komponente liofiliziranega konjugata MenA, ki se ga rekonstituira z 1 vialo komponente tekočega konjugata MenCWY.
English: It should be checked if the adverse reactions may be intensified by any co-administration.
Slovenian: Preveriti je treba, ali sočasno apliciranje morda okrepi neželene učinke.
English: Insufficient clinical data on exposed pregnancies are available.
Slovenian: Na voljo ni zadostnih kliničnih podatkov o uporabi cepiva Menveo pri nosečnicah.
English: 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.
Slovenian: 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.
English: Pack size of one dose (2 vials) or five doses (10 vials).
Slovenian: Velikost pakiranja je en odmerek (2 viali) ali pet odmerkov (10 vial).
English: Please tell your doctor if you have received a previous injection with Menveo or another meningococcal vaccine.
Slovenian: Obvestite zdravnika, če ste že bili cepljeni s cepivom Menveo ali drugim meningokoknim cepivom.
English: Sera were obtained both before vaccination and 1 month after vaccination.
Slovenian: Serum so pridobili pred cepljenjem in 1 mesec po njem.
English: Concomitant administration of Menveo and other vaccines than those listed above has not been studied.
Slovenian: Sočasnega apliciranja cepiva Menveo z drugimi cepivi, ki niso našteta zgoraj, niso preučili.
English: (Originally contained in the solution) • Meningococcal group C oligosaccharide
Slovenian: (Originalno vsebovano v raztopini) • Oligosaharid meningokoka skupine C
English: 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.
Slovenian: 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.
English: After reconstitution, the medicinal product should be used immediately.
Slovenian: Rekonstituirano cepivo je treba uporabiti takoj.
English: (≥1/10,000 to <1/1,000)
Slovenian: (≥1/10.000 do <1/1.000)
English: Do not use this medicine after the expiry date which is stated on the outer carton after EXP.
Slovenian: 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.
English: Menveo has not been evaluated in persons with thrombocytopenia, bleeding disorders or that are receiving anticoagulant therapy, because of the risk of haematoma.
Slovenian: Cepiva Menveo niso ocenili pri osebah s trombocitopenijo, motnjami krvavitev in pri osebah, ki prejemajo zdravila proti strjevanju krvi, saj obstaja tveganje hematoma.
English: Immunogenicity in adolescents
Slovenian: Imunogenost pri mladostnikih
English: In the pivotal immunogenicity trial, V59P13, immune responses to Menveo were assessed among adults aged 19 to 55 years.
Slovenian: V osrednjem preskušanju imunogenosti, V59P13, so bili imunski odzivi na cepivo Menveo ocenjeni med odraslimi, starimi 19 do 55 let.
English: Five doses (10 vials) per package.
Slovenian: Pet odmerkov (10 vial) na pakiranje.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Slovenian: To cepivo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ”brez natrija”.
English: This medicinal products contains less than 1 mmol potassium (39 mg) per dose, i.e. essentially ‘potassium-free'.
Slovenian: To cepivo vsebuje manj kot 1 mmol (39 mg) kalija na odmerek, kar v bistvu pomeni ”brez kalija”.
English: Marketing Authorisation Holder: GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italy
Slovenian: Imetnik dovoljenja za promet: GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italija
English: Menveo can be given concomitantly with any of the following vaccines: monovalent and combined hepatitis A and B, yellow fever, typhoid fever (Vi polysaccharide), Japanese encephalitis, rabies and meningococcal group B (Bexsero).
Slovenian: 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).
English: Menveo will not protect against infections caused by any other serogroups of N. meningitidis not present in the vaccine.
Slovenian: Cepivo Menveo ne ščiti pred okužbami, ki jih povzročajo druge seroskupine bakterije N. meningitidis,
English: Immunogenicity in children 2 to 10 years of age
Slovenian: Imunogenost pri otrocih, starih 2 do 10 let
English: Menveo's effect could be diminished when administered to individuals who are taking medicines that suppress the immune system.
Slovenian: Učinki cepiva Menveo lahko oslabijo, če se cepijo osebe, ki jemljejo zdravila za zaviranje odziva imunskega sistema.
English: To ensure optimal antibody levels against all vaccine serogroups, the primary vaccination schedule with Menveo should be completed one month prior to risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y. Bactericidal antibodies (hSBA≥1:8) were observed in at least 64% of subjects at 1 week post vaccination (see section 5.1 for immunogenicity data per individual serogroups).
Slovenian: 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).
English: There are no data on the applicability of the vaccine for post-exposure prophylaxis.
Slovenian: Ni podatkov o primernosti cepiva za zaščito po izpostavitvi.
English: Uncommon (may affect up to 1 in 100 people): injection site itching
Slovenian: Občasni (pojavijo se lahko pri največ 1 do 100 cepljenih oseb): srbenje na mestu injiciranja
English: 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).
Slovenian: 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).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italy
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italija
English: (≥1/100 to <1/10)
Slovenian: (≥1/100 do <1/10)
English: Menveo is a powder and a solution for injection.
Slovenian: Cepivo Menveo je prašek in raztopina za injiciranje.
English: What Menveo looks like and contents of the pack
Slovenian: Izgled cepiva Menveo in vsebina pakiranja
English: No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: 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).
Slovenian: 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).
English: hSBA GMTs
Slovenian: GMT hSBA
English: Not known: tonic convulsion, febrile convulsion, syncope Ear and labyrinth disorders
Slovenian: Neznana pogostnost: tonične konvulzije, febrilne konvulzije, sinkopa Ušesne bolezni, vključno z motnjami labirinta
English: MARKETING AUTHORISATION HOLDER GSK Vaccines S.r.l.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM GSK Vaccines S.r.l.