natgillin/translations-raw huggingface dataset:
Stopping breathing or irregular breathing for a short time may be more common in the first three days following vaccination in these babies and they may need special monitoring.
Prenehanje dihanja ali nepravilno dihanje za kratek čas je lahko pogostejše v prvih treh dneh po cepljenju prezgodaj rojenih otrok; morda jih bo potrebno posebno spremljati.
Overall, 78% (95% confidence limits from 63-90%) of the approximately 1,000 strains were potentially susceptible to vaccine-induced antibodies.
Skupno 78 % (95-odstotni interval zaupanja: 63-90 %) od približno 1.000 sevov so bili potencialno občutljivi na protitelesa, ki so nastala zaradi cepiva.
Intervals between Primary Doses
Presledki med osnovnimi odmerki
The clinical consequences of the reduced immunogenicity of the NHBA antigen at this schedule are not known.
Klinične posledice zmanjšane imunogenosti antigena NHBA v tej shemi niso znane.
The vaccine must not be injected intravenously, subcutaneously or intradermally and must not be mixed with other vaccines in the same syringe.
Cepiva ne smete injicirati intravensko, subkutano ali intradermalno in ga ne smete zmešati z drugimi cepivi v isti brizgi.
- if you or your child have an allergy to the antibiotic kanamycin.
- če imate vi ali vaš otrok alergijo na antibiotik kanamicin.
Pharmacotherapeutic group: meningococcal vaccines, ATC code: J07AH09
Farmakoterapevtska skupina: cepiva proti meningokokom, oznaka ATC: J07AH09 Mehanizem delovanja
Before use, the pre-filled syringe should be well shaken in order to form a homogeneous suspension.
Pred uporabo je treba napolnjeno injekcijsko brizgo dobro pretresti, da nastane homogena suspenzija.
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 natrija (23 mg) na odmerek, kar v bistvu pomeni „brez natrija“.
As these antigens are variably expressed by different strains, meningococci that express them at sufficient levels are susceptible to killing by vaccine-elicited antibodies.
Ker se ti antigeni spremenljivo izražajo s strani različnih sevov, so meningokoki, ki jih izražajo v zadostnih količinah, dovzetni za uničenje s pomočjo protiteles, ki jih izzove cepivo.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before Bexsero is given.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden prejmete cepivo Bexsero.
Allergic reactions that may include severe swelling of the lips, mouth, throat (which may cause difficulty in swallowing), difficulty breathing with wheezing or coughing, rash, loss of consciousness and very low blood pressure.
Alergijske reakcije, ki lahko vključujejo hudo otekanje ustnic, ust, žrela (kar povzroči oteženo požiranje), oteženo dihanje s sopenjem ali kašljanjem, izpuščaj, izgubo zavesti in zelo nizek krvni tlak.
Nevertheless, vaccination should not be withheld when there is a clear risk of exposure to meningococcal infection.
Vendar se cepljenja ne sme zadržati v primeru jasnega tveganja izpostavitve okužbi z meningokokom.
The efficacy of Bexsero has not been evaluated through clinical trials.
Učinkovitost cepiva Bexsero ni bila ovrednotena v kliničnih preskušanjih.
If present, the kanamycin level in the vaccine is low.
Če je kanamicin prisoten, je njegova raven v cepivu majhna.
The tip cap of the syringe may contain natural rubber latex.
Zaporka konice brizge lahko vsebuje lateks iz naravne gume.
There are no data on fertility in humans.
Ni podatkov o učinkih na plodnost pri človeku.
Experience of overdose is limited.
Izkušenj s prevelikim odmerjanjem je malo.
Other medicines and Bexsero
Druga zdravila in cepivo Bexsero
However, some of the effects mentioned under section 4.8 “Undesirable effects” may temporarily affect the ability to drive or use machines.
Vendar lahko nekateri učinki, našteti v poglavju 4.8 „Neželeni učinki“, začasno vplivajo na sposobnost vožnje in upravljanja s stroji.
Prophylactic use of paracetamol reduces the incidence and severity of fever without affecting the immunogenicity of either Bexsero or routine vaccines.
Profilaktična uporaba paracetamola zmanjša pojavnost in resnost zvišane telesne temperature brez vpliva na imunogenost bodisi cepiva Bexsero bodisi rutinskih cepiv.
- if you or your child receive treatment that blocks the part of the immune system known as complement activation, such as eculizumab.
- če vi ali vaš otrok prejemate zdravila, ki blokirajo del imunskega sistema, imenovan aktivacija komplementa, na primer ekulizumab.
A survey of approximately 1,000 different invasive meningococcal group B isolates collected during 2007-2008 in 5 European countries showed that, depending on the country of origin, between 73% and 87% of meningococcal group B isolates had an appropriate MATS antigen profile to be covered by the vaccine.
Pregled približno 1.000 različnih izolatov invazivnih meningokokov skupine B, zbranih v letih od 2007 do 2008 v 5 evropskih državah, je pokazal, da ima (odvisno od države izvora) med 73 % do 87 % izolatov meningokokov skupine B ustrezen MATS antigenski profil, ki ga pokriva cepivo.
If you or your child have weakened immunity (for example, due to the use of immunosuppressive medications, or HIV infection, or hereditary defects of the body's natural defence system), it is possible that the effectiveness of Bexsero is reduced.
Če ste vi ali vaš otrok imunsko oslabeli (npr. zaradi uporabe imunosupresivnih zdravil, okužbe z virusom HIV ali dednih okvar naravnega telesnega obrambnega sistema), je možno, da bo učinkovitost cepiva Bexsero zmanjšana.
Adsorbed on aluminium hydroxide (0.5 mg Al³+).
Adsorbirano na aluminijev hidroksid (0,5 mg Al3+).
The safety of Bexsero was evaluated in 17 studies including 10 randomised controlled clinical trials with 10565 subjects (from 2 months of age) who received at least one dose of Bexsero.
Varnost cepiva Bexsero je bila ocenjena v 17 študijah, vključno z 10 randomiziranimi, kontroliranimi kliničnimi preskušanji z 10565 preiskovanci (starimi vsaj 2 meseca), ki so prejeli vsaj en odmerek cepiva Bexsero.
This vaccine should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration.
Tega cepiva ne smete dajati osebam s trombocitopenijo ali motnjo koagulacije, pri kateri je intramuskularno injiciranje kontraindicirano, razen če pričakovane koristi jasno odtehtajo tveganje uporabe.
As with many vaccines, healthcare professionals should be aware that a temperature elevation may occur following vaccination of infants and children (less than 2 years of age).
Kot pri mnogih cepivih, morajo zdravniki upoštevati, da se lahko po cepljenju dojenčkov in otrok (starih do 2 let) pojavi zvišana telesna temperatura.
Prophylactic administration of antipyretics at the time and closely after vaccination can reduce the incidence and intensity of post-vaccination febrile reactions.
Profilaktično dajanje antipiretikov sočasno s cepljenjem in neposredno po njem lahko zmanjša pojavnost in intenzivnost febrilnih reakcij po cepljenju.
This will help to reduce some of the side effects of Bexsero.
S tem boste zmanjšali nekatere neželene učinke cepiva Bexsero.
Like all vaccines, this vaccine can cause side effects, although not everybody gets them.
Kot vsa cepiva ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh uporabnikih.
Name and address of the manufacturers of the biological active substance (OMV):
Ime in naslov izdelovalcev biološke zdravilne učinkovine (OMV):
In the event of any foreign particulate matter and/or variation of physical aspect being observed, do not administer the vaccine.
V primeru prisotnosti tujih delcev in/ali če opazite spremembo izgleda, cepiva ne uporabite.
Adverse reactions (following primary immunisation or booster dose) considered as being at least possibly related to vaccination have been categorised by frequency.
Neželeni učinki (po osnovni imunizaciji ali poživitvenem odmerku), ki so jih smatrali vsaj za možno povezane s cepljenjem, so razvrščeni po pogostnosti.
Immunogenicity data are available in individuals with complement deficiencies, asplenia, or splenic dysfunctions (see section 5.1).
Na voljo so podatki o imunogenosti pri posameznikih s pomanjkljivostmi komplementa, asplenijo ali nepravilnim delovanjem vranice (glejte poglavje 5.1).
Concomitant administration of Bexsero with vaccines other than those mentioned above has not been studied.
Sočasna uporaba cepiva Bexsero s cepivi, ki zgoraj niso omenjena, ni bila preučena.
Children and adolescents with complement deficiencies, asplenia, or splenic dysfunction
Otroci in mladostniki s pomanjkljivostmi komplementa, asplenijo ali nepravilnim delovanjem vranice
Bellaria-Rosia IT-53018 Sovicille-Siena Italy
Bellaria-Rosia IT-53018 Sovicille-Siena Italija
Among Bexsero recipients, 6837 were infants and children (less than 2 years of age), 1051 were children (2 to 10 years of age) and 2677 were adolescents and adults.
Med prejemniki cepiva Bexsero je bilo 6837 dojenčkov in otrok (starih do 2 leti), 1051 otrok (starih od 2 do 10 let) ter 2677 mladostnikov in odraslih oseb.
Information on the safety of the vaccine to women and their children during breast-feeding is not available.
Podatki o varnosti cepiva pri ženskah in dojenih otrocih niso na voljo.
An early immune response after the first dose was also evaluated.
Ocenjevali so tudi zgodnji imunski odziv po prvem odmerku.
When fever occurred, it generally followed a predictable pattern, with the majority resolving by the day after vaccination.
Pojav zvišane telesne temperature je sledil predvidljivemu vzorcu, pri čemer je večina primerov izzvenela do naslednjega dne po cepljenju.
Bellaria-Rosia 53018 Sovicille (Siena) Italy.
Bellaria-Rosia 53018 Sovicille (Siena) Italija
Bexsero contains sodium chloride
Cepivo Bexsero vsebuje natrijev klorid
If you or your child may have allergy to kanamycin, talk to your doctor or nurse first.
Če imate vi ali vaš otrok alergijo na kanamicin, se najprej posvetujte s svojim zdravnikom ali medicinsko sestro.
Talk to your doctor or nurse first.
Najprej se posvetujte s svojim zdravnikom ali medicinsko sestro.
Sodium chloride, histidine, sucrose and water for injections (see section 2 for further information on sodium and latex).
Druge sestavine: natrijev klorid, histidin, saharoza in voda za injekcije (glejte poglavje 2 za več informacij o natriju in lateksu).
This leaflet was last revised in {MM/YYYY}
Navodilo je bilo nazadnje revidirano dne.
Read all of this leaflet carefully before you or your child receive this medicine because it contains important information for you or your child.
Preden vi ali vaš otrok prejmete to cepivo, natančno preberite navodilo, ker vsebuje pomembne podatke za vas in vašega otroka!
For adsorbent see section 2.
Adsorbent je naveden v poglavju 2.
Care must be taken to ensure that the vaccine is injected intramuscularly only.
Pazite, da cepivo injicirate samo intramuskularno.
Collapse (sudden onset of muscle floppiness), less responsive than usual or lack of awareness, and paleness or bluish skin discoloration in young children.
Kolaps (nenaden pojav telesne oslabelosti), manjša odzivnost kot ponavadi ali pomanjkanje zaznavanja, bledica ali modrikasto obarvanje kože pri mlajših otrocih.
The same extension study also evaluated antibody persistence and the response to a booster dose in children who received the two-dose primary series at 2-5 or 6-10 years of age.
Ista podaljšana študija je ocenila tudi vztrajanje protiteles in odziv na poživitveni odmerek pri otrocih, ki so prejeli primarno zaporedje z dvema odmerkoma v starosti od 2 do 5 let ali od 6 do 10 let.
Individuals with impaired immune responsiveness, whether due to the use of immune-suppressive therapy, a genetic disorder, or other causes, may have reduced antibody response to active immunisation.
Posamezniki z oslabljenim imunskim odzivom, bodisi zaradi uporabe imunosupresivnih zdravil, genetske motnje ali drugih vzrokov, imajo lahko zmanjšan odziv protiteles na aktivno imunizacijo.
Infants and children (up to 10 years of age)
Dojenčki in otroci (do 10 let starosti)
Very common: sleepiness, unusual crying, headache Uncommon: seizures (including febrile seizures)
Zelo pogosti: zaspanost, neobičajno jokanje, glavobol Občasni: krči (vključno s febrilnimi krči)
In case of delay, the booster should not be given later than 24 months of age.
V primeru zamika otrok poživitvenega odmerka ne sme prejeti pozneje kot pri 24 mesecih starosti.
Inconsistent results were seen across studies for responses to inactivated poliovirus type 2 and pneumococcal conjugate serotype 6B and lower antibody titers to the pertussis pertactin antigen were also noted, but these data do not suggest clinically significant interference.
V študijah so se pokazali nedosledni rezultati odziva na inaktiviran poliovirus tipa 2 in pnevmokokni konjugat serotipa 6B ter manjši titri protiteles proti antigenu pertaktinu oslovskega kašlja, vendar ti podatki ne kažejo klinično pomembne interference.
However, some of the effects mentioned under section 4 “Possible side effects” may temporarily affect the ability to drive or use machines.
Vendar lahko nekateri učinki, našteti v poglavju 4 „Možni neželeni učinki“, začasno vplivajo na sposobnost vožnje in upravljanja s stroji.
There are no data on the use of Bexsero in adults above 50 years of age.
Ni podatkov o uporabi cepiva Bexsero pri odraslih, starejših od 50 let.
Sera were obtained both before vaccination, one month after the third vaccination (see Table 2) and one month after booster vaccination (see Table 3).
Serume so odvzeli pred cepljenjem, en mesec po tretjem cepljenju (glejte preglednico 2) in en mesec po poživitvenem cepljenju (glejte preglednico 3).
The following information is intended for healthcare professionals only: Upon storage a fine off-white deposit may be observed in the pre-filled syringe containing the suspension.
Naslednje informacije so namenjene samo zdravstvenemu osebju: Pri shranjevanju lahko nastane tanka sivobela usedlina v napolnjeni injekcijski brizgi, ki vsebuje suspenzijo.
- if you or your child have haemophilia or any other problem that may stop your blood from clotting properly, such as treatment with blood thinners (anticoagulants).
- če imate vi ali vaš otrok hemofilijo ali drugo težavo, ki preprečuje pravilno strjevanje krvi, na primer zdravljenje z zdravili za redčenje krvi (antikoagulanti).
Of the subjects who received primary infant series of Bexsero, 3285 received a booster dose in the second year of life.
Od preiskovancev, ki so prejeli osnovno shemo odmerkov cepiva Bexsero za dojenčke, jih je 3285 prejelo poživitveni odmerek v drugem letu življenja.
pre-vaccination titer ≥1:4
titer pred cepljenjem ≥ 1:4
Bexsero was immunogenic in maternal animals vaccinated prior to lactation, and antibodies were detected in the offspring, but antibody levels in milk were not determined.
Cepivo Bexsero je bilo imunogeno pri brejih živalih, ki so bile cepljene pred laktacijo, in protitelesa so zaznali v potomcih, vendar ravni protiteles v mleku niso določili.
When Bexsero is given to you or your child, the very common side effects (may affect more than 1 in 10 people) that you or your child may get (reported in all age groups) are: - pain/tenderness at the injection site, redness of the skin at the injection site, swelling of the skin at the injection site, hardness of the skin at the injection site.
Če cepivo Bexsero prejmete vi ali vaš otrok, so zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 oseb), ki se lahko pojavijo pri vas ali vašem otroku (poročani v vseh starostnih skupinah): - bolečina/občutljivost na mestu injiciranja, pordelost kože na mestu injiciranja, oteklina v koži na mestu injiciranja, zatrdlina v koži na mestu injiciranja.
What Bexsero is and what it is used for What you need to know before you or your child receive Bexsero How to use Bexsero
Kaj je cepivo Bexsero in za kaj ga uporabljamo Kaj morate vedeti, preden boste vi ali vaš otrok prejeli cepivo Bexsero Kako uporabljati cepivo Bexsero
In adolescents and adults the most common local and systemic adverse reactions observed were pain at the injection site, malaise and headache.
Pri mladostnikih in odraslih so bili najpogostejši lokalni in sistemski neželeni učinki bolečina na mestu injiciranja, slabo počutje in glavobol.
Bexsero contains four different components from the surface of the bacteria Neisseria meningitidis group B.
Cepivo Bexsero vsebuje štiri različne sestavine iz površine bakterije Neisseria meningitidis skupine B.
LIST OF EXCIPIENTS Excipients: sodium chloride, histidine, sucrose, water for injections.
Pomožne snovi: natrijev klorid, histidin, saharoza, voda za injekcije.
The same study also evaluated antibody persistence data from an additional phase 3 initial study in adolescents.
Ista študija je ocenila tudi podatke o vztrajanju protiteles iz dodatne uvodne študije 3. faze pri mladostnikih.
As with other vaccines, administration of Bexsero should be postponed in subjects suffering from an acute severe febrile illness.
Kot pri drugih cepivih je treba dajanje cepiva Bexsero odložiti pri osebah, ki imajo hudo akutno febrilno bolezen.
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 B, even if they develop antibodies following vaccination with Bexsero.
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 skupine B, čeprav razvijejo protitelesa po cepljenju s cepivom Bexsero.
The European Medicines Agency has deferred the obligation to submit the results of studies with Bexsero in one or more subsets of the paediatric population in the prevention of meningococcal disease caused by Neisseria meningitidis group B (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s cepivom Bexsero za eno ali več podskupin pediatrične populacije za preprečevanje meningokokne bolezni, ki jo povzroča bakterija Neisseria meningitidis skupine B (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
- A booster will be given after an interval of 12 to 23 months from the second injection.
- Poživitveni odmerek se daje od 12 do 23 mesecev po drugi injekciji.
Tell your doctor or nurse if you know that you or your child is allergic to latex.
Posvetujte se s svojim zdravnikom ali medicinsko sestro, če imate vi ali vaš otrok alergijo na lateks.
6.6 Special precautions for disposal and other handling Upon storage a fine off-white deposit may be observed in the pre-filled syringe containing the suspension.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Pri shranjevanju lahko v napolnjeni injekcijski brizgi, ki vsebuje suspenzijo, nastane tanka belkasta usedlina.
35 to 47 months of age 4 to 7 years of age 8 to10 years of age fHbp
Antigen starost od 35 do 47 mesecev starost od 4 do 7 let starost od 8 do 10 let fHbp
Bexsero must not be mixed with other vaccines in the same syringe.
Cepiva Bexsero ne smete zmešati z drugimi cepivi v isti injekcijski brizgi.
The safe use of Bexsero in kanamycin-sensitive individuals has not been established.
Varnost uporabe cepiva Bexsero pri osebah, občutljivih na kanamicin, ni ugotovljena.
For instructions on the handling of the vaccine before administration, see section 6.6.
Za navodila glede ravnanja s cepivom pred dajanjem glejte poglavje 6.6. 4.3 Kontraindikacije
The presence of a minor infection, such as a cold, should not require postponement of the vaccination, but talk to your doctor or nurse first.
Cepljenja ni potrebno odložiti zaradi manjše okužbe kot je prehlad, vendar se najprej posvetujte s svojim zdravnikom ali medicinsko sestro.
If two needles of different lengths are provided in the pack, choose the appropriate needle to ensure an intramuscular administration.
Če sta v pakiranju igli različnih dolžin, izberite iglo, ki je primerna za intramuskularno dajanje.
If you have any further questions on Bexsero, ask your doctor or nurse.
Če imate dodatna vprašanja o cepivu Bexsero, se posvetujte z zdravnikom ali medicinsko sestro.
White opalescent liquid suspension.
Bela opalescentna tekoča suspenzija.
Antibody persistence was evaluated in an extension study in children 3 to 4 years of age.
Vztrajanje protiteles so ocenili v podaljšani študiji pri otrocih v starosti od 3 do 4 let.
When Bexsero was given alone, the frequency of fever was similar to that associated with routine infant vaccines administered during clinical trials.
Če je bilo cepivo Bexsero dano samo, je bila pogostnost zvišane telesne temperature podobna kot pri rutinskih cepivih za dojenčke, ki so bila uporabljena med kliničnimi preskušanji.
Vaccine efficacy has been inferred by demonstrating the induction of serum bactericidal antibody responses to each of the vaccine antigens (see section Immunogenicity).
Učinkovitost cepiva je bila izpeljana z dokazom indukcije odziva serumskih baktericidnih protiteles na posamezne antigene cepiva (glejte podpoglavje Imunogenost).
In addition to reports in clinical trials, worldwide voluntary reports of adverse reactions received for Bexsero since market introduction are included in the list.
Poleg poročil iz kliničnih preskušanj so v seznam vključena tudi spontana poročila o neželenih učinkih cepiva Bexsero po prihodu zdravila na trg.
There are limited data on the use of Bexsero in patients with chronic medical conditions or with weakened immunity.
Na voljo je malo podatkov o uporabi cepiva Bexsero pri bolnikih s kroničnimi boleznimi ali z oslabljeno imunostjo.
In the study in adolescents, bactericidal responses following two doses of Bexsero were stratified by baseline hSBA less than 1:4 or equal to or greater than 1:4.
V študiji pri mladostnikih so baktericidne odzive po dveh odmerkih cepiva Bexsero stratificirali po izhodiščnem rezultatu hSBA manj od 1:4 ali enako ali več od 1:4.
It will be injected into a muscle, usually the thigh for infants or the upper arm for children, adolescents and adults.
Injicira se v mišico, ponavadi v stegno pri dojenčkih ali nadlaket pri otrocih, mladostnikih in odraslih.
Antibody persistence data for the study in adolescents were obtained in an extension phase 3 study.
Podatki o vztrajanju protiteles za študijo pri mladostnikih so bili zbrani v podaljšani študiji 3. faze.
Your doctor may still recommend that you receive Bexsero if you are at risk of exposure to meningococcal infection.
Zdravnik vam bo morda kljub temu priporočil cepljenje s cepivom Bexsero, če pri vas obstaja tveganje za izpostavljenost meningokokni okužbi.
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use only.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Samo za intramuskularno uporabo.
The first dose should be given no earlier than 2 months of age.
Prvega odmerka ne smete dati pred 2. mesecem starosti.
In an extension study the persistence of the immune response was assessed one year after the booster dose (see Table 3).
V podaljšani študiji so perzistenco imunskega odziva ocenjevali eno leto po poživitvenem odmerku (glejte preglednico 3).
Similar responses were also observed for adolescents administered two doses of Bexsero with an interval of six months.
Podobni odzivi so bili opaženi tudi pri mladostnikih, ki so prejeli dva odmerka cepiva Bexsero s šestmesečnim presledkom.