FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no data on the use of Trumenba in subjects above 65 years of age.
Slovenian: Podatkov o uporabi cepiva Trumenba pri preskušancih, starejših od 65 let, ni na voljo.
English: A booster response in hSBA responses at 1 month following a dose of Trumenba approximately 4 years after a primary series of 2 doses (Group 3) or 3 doses (Groups 1 and 2) was observed.
Slovenian: Pri odzivih hSBA so odziv na obnovitveni odmerek opazili 1 mesec po odmerku cepiva Trumenba, danega približno 4 leta po osnovni shemi cepljenja z 2 odmerkoma (Skupina 3) ali 3 odmerki cepiva (Skupini 1 in 2).
English: 1 Month after last primary Dose
Slovenian: 1 mesec po zadnjem osnovnem odmerku
English: In Studies B1971009 and B1971016, the proportion of subjects achieving a defined hSBA titre after 3 doses of Trumenba, administered on a 0-, 2-, and 6-month schedule, was evaluated against a panel of 10 additional strains, each expressing a different fHbp variant (Table 5).
Slovenian: V Študijah B1971009 in B1971016 so delež preskušancev, ki so dosegli opredeljeni titer hSBA po 3 odmerkih cepiva Trumenba, danega po shemi 0., 2. in 6. mesec, ocenili proti naboru 10 dodatnih sevov, od katerih je vsak izražal drugačno varianto beljakovine fHbp (preglednica 5).
English: Manufacturer responsible for batch release: Pfizer Manufacturing Belgium N.V. Rijksweg 12
Slovenian: Izdelovalec, odgovoren za sproščanje serij: Pfizer Manufacturing Belgium N.V.
English: Study B1971016 was a Phase 3, randomised, placebo-controlled, observer-blinded, multicentre trial in which subjects 18 to 25 years of age were assigned to 2 groups in a 3:1 ratio (Group 1:Group 2).
Slovenian: Študija B1971016 je bilo randomizirano, s placebom nadzorovano, za opazovalca slepo, multicentrično preskušanje 3. faze, v katerem so preskušance, stare od 18 do 25 let, razdelili v 2 skupini v razmerju 3:1 (Skupina 1 : Skupina 2).
English: Trumenba is indicated for active immunisation of individuals 10 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.
Slovenian: Cepivo Trumenba je indicirano za aktivno imunizacijo posameznikov, starih 10 let in več, proti invazivni meningokokni bolezni, ki jo povzroča Neisseria meningitidis serološke skupine B.
English: This process is measured in vitro with serum bactericidal assay using human complement (hSBA) for meningococcal serogroup B. An hSBA titre of greater than or equal 1:4 is assumed to be protective against meningococcal disease.
Slovenian: Ta proces merijo in vitro s preskusom baktericidnosti v serumu s humanim komplementom (hSBA) za meningokoke serološke skupine B. Titer hSBA, ki je večji ali enak 1:4, domnevno zaščiti pred meningokokno boleznijo.
English: It is important to follow the instructions from the doctor, pharmacist or nurse so that you or your child completes the course of injections.
Slovenian: Pomembno je, da upoštevate navodila zdravnika, farmacevta ali medicinske sestre in da vi oziroma vaš otrok prejmete vse predvidene odmerke.
English: All subjects received 4 study injections, either 2 or 3 doses of Trumenba and 1 or 2 doses of saline.
Slovenian: Vsi preskušanci so v preskušanju prejeli 4 injekcije, in sicer 2 oziroma 3 odmerke cepiva Trumenba in 1 oziroma 2 odmerka fiziološke raztopine.
English: A composite response was defined as a response for all 4 hSBA strains combined.
Slovenian: Sestavljeni odziv so opredelili kot porast pri vseh 4 sevih v hSBA skupaj.
English: Composite response (A response for all 4 hSBA strains combined) 1 Month after last primary Dose
Slovenian: Sestavljeni odziv (odziv pri vseh 4 sevih v hSBA skupaj) 1 mesec po zadnjem osnovnem odmerku
English: Reproduction studies performed in female rabbits have revealed no evidence of impaired female fertility or harm to the foetus due to Trumenba.
Slovenian: Študije vpliva na sposobnost razmnoževanja pri kunčjih samicah niso pokazale zmanjšane plodnosti samic zaradi cepiva Trumenba ali škodljivih učinkov tega cepiva na plod.
English: See section 5.1 for information on the immune response against specific serogroup B strains.
Slovenian: Za informacije o imunskem odzivu na specifične seve serološke skupine B glejte poglavje 5.1.
English: Immunisation with Trumenba, which contains one fHbp variant each from subfamily A and B, is intended to stimulate the production of bactericidal antibodies that recognize fHbP expressed by meningococci.
Slovenian: Namen imunizacije s cepivom Trumenba, ki vsebuje po eno varianto beljakovine fHbp iz podskupin A in B, je spodbuditi tvorbo baktericidnih protiteles, ki prepoznavajo beljakovino fHbp, ki jo izražajo meningokoki.
English: Trumenba suspension for injection in pre-filled syringe Meningococcal group B vaccine (recombinant, adsorbed)
Slovenian: Trumenba suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti meningokokom skupine B (rekombinantno, adsorbirano)
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Trumenba is a white suspension for injection, provided in a pre-filled syringe.
Slovenian: Cepivo Trumenba je bela suspenzija za injiciranje v napolnjeni injekcijski brizgi.
English: Vaccine efficacy has been inferred by demonstrating the induction of serum bactericidal antibody responses to 4 meningococcal serogroup B test strains (see the Immunogenicity section).
Slovenian: O učinkovitosti cepiva so sklepali iz prikaza indukcije odzivov baktericidnih protiteles v serumu na 4 testne seve meningokokov serološke skupine B (glejte poglavje Imunogenost).
English: The vaccine should be visually inspected for particulate matter and discoloration prior to administration.
Slovenian: Pred uporabo je treba cepivo pregledati glede prisotnosti vidnih delcev in obarvanosti.
English: Study B1971009 was a Phase 3, randomised, active-controlled, observer-blinded, multicentre trial in which subjects aged 10 to 18 years received 1 of 3 lots (Groups 1, 2, and 3) of Trumenba or the active control hepatitis A virus (HAV) vaccine/saline.
Slovenian: Študija B1971009 je bilo randomizirano, z učinkovino nadzorovano, za opazovalca slepo, multicentrično preskušanje 3. faze, v katerem so preskušanci, stari od 10 do 18 let, prejeli 1 od 3 serij (Skupine 1, 2 in 3) cepiva Trumenba ali kontrolno cepivo proti hepatitisu A (HAV)/fiziološko raztopino.
English: Trumenba can be given at the same time as any of the following vaccine components: tetanus, diphtheria, whooping cough (pertussis), poliovirus, papillomavirus, and meningococcal serogroups A, C, Y, W.
Slovenian: Cepivo Trumenba se lahko daje sočasno s katerokoli od naslednjih sestavin cepiv: tetanus, davica, oslovski kašelj, otroška paraliza, papiloma virus in meningokoki seroloških skupin A, C, Y, W.
English: N % (95% CI)
Slovenian: n % (95 % IZ)
English: A booster dose should be considered following either dosing regimen for individuals at continued risk of invasive meningococcal disease (see section 5.1).
Slovenian: Pri posameznikih s stalnim tveganjem za invazivno meningokokno bolezen je po kateremkoli od obeh režimov odmerjanja treba razmisliti o obnovitvenem odmerku (glejte poglavje 5.1).
English: Non-clinical data revealed no special hazard for humans based on conventional studies of repeated dose toxicity and reproduction and developmental toxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih ter vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: hSBA Strain (fHbp Variant)
Slovenian: Sev v hSBA (varianta fHbp)
English: White liquid suspension.
Slovenian: suspenzija za injiciranje bela tekoča suspenzija
English: The immunogenicity of Trumenba following 2 or 3 vaccinations was evaluated in individuals 11 to 18 years of age in Europe (Study B1971012) and following 3 vaccinations in individuals 10 to 25 years of age globally (Studies B1971009 and B1971016).
Slovenian: Imunogenost cepiva Trumenba po 2 ali 3 cepljenjih so ocenili pri posameznikih, starih od 11 do 18 let, v Evropi (Študija B1971012) in po 3 cepljenjih pri posameznikih, starih od 10 do 25 let, po vsem svetu (Študija B1971009 in Študija B1971016).
English: GMT (95% CI)
Slovenian: GMT (95 % IZ)
English: Group 1
Slovenian: Skupina 1
English: Subjects attended visits over 4 years for collection of blood samples and received a single booster dose of Trumenba approximately 4 years after receipt of a primary series of 2 or 3 doses of Trumenba.
Slovenian: Preskušanci so več kot 4 leta prihajali na odvzem krvnih vzorcev, približno 4 leta po prejemu cepiva Trumenba po osnovni shemi cepljenja z 2 ali 3 odmerki pa so prejeli enkratni obnovitveni odmerek cepiva Trumenba.
English: Immunocompromised individuals, including individuals receiving immunosuppressant therapy, may have a diminished immune response to Trumenba.
Slovenian: Podatkov o uporabi cepiva Trumenba pri imunoinkompetentnih posameznikih ni. Imunoinkompetentni posamezniki, vključno s posamezniki, ki prejemajo imunosupresivno zdravljenje, imajo lahko zmanjšan imunski odziv na cepivo Trumenba.
English: When given at the same time with other vaccines Trumenba must be given at separate injection sites.
Slovenian: Če ga dajete sočasno z drugimi cepivi, je treba cepivo Trumenba injicirati na drugo mesto injiciranja.
English: Marketing Authorisation Holder: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles
Slovenian: Imetnik dovoljenja za promet z zdravilom: Pfizer Europe MA EEIG Boulevard de la Plaine 17
English: Dose 3 351
Slovenian: 3. odmerek 351
English: Do not administer intravascularly or subcutaneously.
Slovenian: Cepiva ne smete aplicirati intravaskularno ali subkutano.
English: Trumenba has not been evaluated for impairment of fertility in males.
Slovenian: Vpliva cepiva Trumenba na zmanjšanje plodnosti pri samcih niso ovrednotili.
English: Polysorbate 80 (E433) Water for injections For adsorbent, see section 2.
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid histidin polisorbat 80 (E433) voda za injekcije za adsorbent glejte poglavje 2
English: Group 4
Slovenian: Skupina 4
English: During storage, a white deposit and clear supernatant may be observed in the pre-filled syringe containing the suspension.
Slovenian: Med shranjevanjem lahko v napolnjeni injekcijski brizgi, ki vsebuje suspenzijo, nastaneta bela usedlina in bister supernatant.
English: (0, 2, and 6 Months)
Slovenian: (0., 2. in 6. mesec)
English: Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000)
Slovenian: Občasni (≥ 1/1.000 do < 1/100)
English: Abbreviations: hSBA=serum bactericidal assay using human complement; fHbp=factor H binding protein.
Slovenian: Okrajšave: hSBA = preskus baktericidnosti v serumu s humanim komplementom; fHbp = faktor H-vezavna beljakovina.
English: How to store Trumenba
Slovenian: Kako uporabljati cepivo Trumenba
English: Dose 3 362
Slovenian: 3. odmerek 362
English: (0, 1, and 6 Months)
Slovenian: (0., 1. in 6. mesec)
English: Dose 3 360
Slovenian: 3. odmerek 360
English: Trumenba can be given concomitantly with any of the following vaccines: Tetanus Toxoid, Reduced Diphtheria Toxoid, Acellular Pertussis, and Inactivated Poliovirus Vaccine (TdaP-IPV), Quadrivalent Human Papillomavirus vaccine (HPV4), Meningococcal Serogroups A, C, Y, W conjugate vaccine (MenACWY) and Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap).
Slovenian: Cepivo Trumenba lahko dajemo sočasno s katerimkoli od naslednjih cepiv: cepivom s tetanusnim toksoidom, prečiščenim davičnim toksoidom, acelularnim cepivom proti oslovskemu kašlju in inaktiviranimi poliovirusi (TdaP-IPV), tetravalentnim cepivom proti humanemu papiloma virusu
English: Abbreviations: GMT=geometric mean titre; hSBA=serum bactericidal assay using human complement; fHBP=factor H binding protein.
Slovenian: Okrajšave: GMT = geometrična sredina titrov, hSBA = preskus baktericidnosti v serumu s humanim komplementom; fHbp = faktor H-vezavna beljakovina.
English: ≥ 4-Fold rise in hSBA titre (%)
Slovenian: ≥ 4-kratno povečanje titra hSBA (%)
English: What Trumenba contains
Slovenian: Kaj vsebuje cepivo Trumenba
English: Pfizer Manufacturing Belgium N.V. Rijksweg 12
Slovenian: Pfizer Manufacturing Belgium N.V.
English: Group 3
Slovenian: Skupina 3
English: Group 2
Slovenian: Skupina 2
English: Nervous system disorders Very Common: Headache
Slovenian: Bolezni živčevja Zelo pogosti:
English: Group 1 received Trumenba at months 0, 2, and 6.
Slovenian: Skupina 1 je v 0., 2. in 6. mesecu prejela cepivo Trumenba, Skupina 2 pa fiziološko raztopino.
English: Trumenba suspension for injection Meningococcal B vaccine IM
Slovenian: Trumenba suspenzija za injiciranje cepivo proti meningokokom skupine B i.m.
English: Composite response (A response for all 4 hSBA strains combined) Before
Slovenian: Sestavljeni odziv (odziv pri vseh 4 sevih v hSBA skupaj) pred 1. odmerkom
English: Dose 3 337
Slovenian: 3. odmerek 337
English: Musculoskeletal and connective tissue disorders Very Common: Muscle pain (myalgia); joint pain (arthralgia)
Slovenian: bolečina v mišicah (mialgija), bolečina v sklepih (artralgija)
English: Dose 3 356
Slovenian: 3. odmerek 356
English: Dose 3 354
Slovenian: 3. odmerek 354
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: The hSBA responses observed after the second or third dose for Groups 1, 2, and 3 are presented in Tables 1 and 2.
Slovenian: Preglednici 1 in 2 prikazujeta odzive hSBA, opažene po drugem oziroma tretjem odmerku pri Skupinah 1, 2 in 3.
English: Bactericidal antibodies act in concert with human complement to kill meningococci.
Slovenian: Pri uničevanju meningokokov baktericidna protitelesa delujejo usklajeno s humanim komplementom.
English: Dose 3 347
Slovenian: 3. odmerek 347
English: This is a type of bacteria that can cause serious and sometimes life threatening infections such as meningitis (inflammation of the covering of the brain and spinal cord) and sepsis (blood poisoning).
Slovenian: Cepivo Trumenba se uporablja pri osebah, starih 10 let in več, za preprečevanje invazivne meningokokne bolezni, ki jo povzročajo bakterije Neisseria meningitidis serološke skupine B. To je vrsta bakterij, ki lahko povzroči resne in včasih življenjsko ogrožajoče okužbe, kot sta meningitis (vnetje ovojnic možganov in hrbtenjače) in sepsa (okužba krvi).
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite kateregakoli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Pack sizes of 1, 5, and 10 pre-filled syringes, with or without needle.
Slovenian: Pakiranja po 1, 5 in 10 napolnjenih injekcijskih brizg, z iglami ali brez njih.
English: The Meningococcal Antigen Surface Expression (MEASURE) assay was developed to relate the level of fHbp surface expression to killing of meningococcal serogroup B strains in serum bactericidal assays with human complement (hSBAs).
Slovenian: Za raziskavo povezave med stopnjo izražanja beljakovine fHbp na površini in uničenjem sevov meningokokov serološke skupine B v preskusih baktericidnosti v serumu s humanim komplementom (hSBA - human Serum Bactericidal Assay) so razvili preskus izražanja meningokoknih antigenov na površini (MEASURE - Meningococcal Antigen Surface Expression).
English: Trumenba should not be mixed with other vaccines in the same syringe.
Slovenian: Cepiva Trumenba ne smemo mešati z drugimi cepivi v isti injekcijski brizgi.
English: Trumenba must not be mixed with any other vaccines in the same syringe.
Slovenian: Cepiva Trumenba ne smete mešati z drugimi cepivi v isti injekcijski brizgi.
English: Neisseria meningitidis serogroup B fHbp subfamily A and B
Slovenian: fHbp iz Neisseria meningitidis serološke skupine B, podskupina A
English: (0 and 6 Months)
Slovenian: (0. in 6. mesec)
English: The hSBA responses for subjects enrolled from primary Study B1971012 Group 1 (0-, 1-, 6-Month Schedule), Group 2 (0-, 2-, 6-Month) and Group 3 (0-, 6-Month) are presented in Tables 6 and 7.
Slovenian: Preglednici 6 in 7 prikazujeta odzive hSBA pri preskušancih, vključenih iz Skupine 1 (shema 0., 1., 6. mesec), Skupine 2 (0., 2., 6. mesec) in Skupine 3 (0., 6. mesec) iz primarne Študije B1971012.
English: Table 2: Immune Responses Among Individuals 11 to 18 Years of Age Administered Trumenba After Various 2- and 3-Dose Schedules (Study B1971012) Group 1
Slovenian: Preglednica 2: Imunski odzivi pri posameznikih, starih 11-18 let, ki so prejemali cepivo Trumenba po različnih shemah z 2 in 3 odmerki (Študija B1971012) Skupina 1
English: Table 6: Persistence of Immune and Booster Responses Among Individuals 11 to 18 Years of Age Administered a Primary Series of Trumenba on a 0-, 1-, 6-Month-; 0-, 2-, 6-Month- and 0-, 6-Month Schedule and a Booster 4 Years After Primary Series (Study B1971033) Primary Study B1971012 Vaccine Group (as Randomised) Group 1
Slovenian: Preglednica 6: Vztrajanje imunskega odziva in odziva na obnovitveni odmerek pri posameznikih, starih 11-18 let, ki so prejeli osnovno cepljenje s cepivom Trumenba po shemi 0., 1., 6. mesec, 0., 2., 6. mesec in 0., 6. mesec ter obnovitveni odmerek 4 leta po osnovnem cepljenju (Študija B1971033) Skupina, ki je prejela cepivo v primarni Študiji B1971012 (skladno z randomizacijo)
English: Table 1: Immune Responses Among Individuals 11 to 18 Years of Age Administered Trumenba After Various 2- and 3-Dose Schedules (Study B1971012) Group 1
Slovenian: Preglednica 1: Imunski odzivi pri posameznikih, starih 11-18 let, ki so prejemali cepivo Trumenba po različnih shemah z 2 in 3 odmerki (Študija B1971012) Skupina 1
English: Vomiting
Slovenian: bruhanje
English: General disorders and administration site conditions Very Common: Chills; fatigue; redness (erythema), swelling (induration) and pain at injection site Common:
Slovenian: mrzlica, utrujenost, pordelost (eritem), oteklina (zatrdlina) in bolečina na mestu injiciranja
English: % hSBA ≥ 1:16 Dose 2 351
Slovenian: % hSBA ≥ 1:16 2. odmerek 351
English: Outer Carton Pack of 1, 5 or 10 pre-filled syringes; with or without needles
Slovenian: Škatla s pakiranjem po 1, 5 ali 10 napolnjenih injekcijskih brizg, z iglami ali brez njih
English: Your doctor may still recommend that you receive Trumenba if you are at risk of meningococcal disease.
Slovenian: Če pri vas obstaja tveganje za meningokokno bolezen, vam bo zdravnik morda kljub temu priporočil cepljenje s cepivom Trumenba.
English: hSBA GMT Dose 2 344
Slovenian: GMT hSBA 2. odmerek 344
English: The hSBA responses observed after the third dose in Groups 1 and 2 are presented in Tables 3 and 4.
Slovenian: Preglednici 3 in 4 prikazujeta odzive hSBA, opažene po tretjem odmerku v Skupinah 1 in 2.
English: Immune Responses Among Individuals 10 to 25 Years of Age Against 10 Additional Strains 1 Month Following the Third Dose of Trumenba Given on a 0-, 2-, 6-Month Schedule (Study B1971009 and Study B1971016) Study B1971009
Slovenian: Imunski odzivi pri posameznikih, starih 10-25 let, na 10 dodatnih sevov 1 mesec po tretjem odmerku cepiva Trumenba po shemi 0., 2., 6. mesec (Študija B1971009 in Študija B1971016) Študija B1971009
English: hSBA GMT Dose 2 351
Slovenian: GMT hSBA 2. odmerek 351
English: Neisseria meningitidis serogroup B fHbp subfamily B
Slovenian: 60 mikrogramov fHbp iz Neisseria meningitidis serološke skupine B, podskupina B
English: hSBA GMT Dose 2 341
Slovenian: GMT hSBA 2. odmerek 341
English: Pre-filled syringe label
Slovenian: Nalepka na napolnjeni injekcijski brizgi
English: hSBA GMT Dose 2 353
Slovenian: GMT hSBA 2. odmerek 353
English: Sodium Chloride Histidine
Slovenian: Trumenba fiziološka raztopina
English: The hSBA responses observed after the third dose in Group 1 are presented in Tables 3 and 4.
Slovenian: Preglednici 3 in 4 prikazujeta odzive hSBA, opažene po tretjem odmerku v Skupini 1.
English: Immune system disorder Not known:
Slovenian: • imate oslabljen imunski sistem.
English: 1 Month after booster Dose
Slovenian: 1 mesec po obnovitvenem odmerku 59
English: Table 7: Persistence of Immune and Booster Responses Among Individuals 11 to 18 Years of Age Administered a Primary Series of Trumenba on a 0-, 1-, 6-Month-; 0-, 2-, 6-Month- and 0-, 6-Month Schedule and a Booster 4 Years After Primary Series (Study B1971033) Primary Study B1971012 Vaccine Group (as Randomised) Group 1
Slovenian: Preglednica 7: Vztrajanje imunskega odziva in odziva na obnovitveni odmerek pri posameznikih, starih 11-18 let, ki so prejeli osnovno cepljenje s cepivom Trumenba po shemi 0., 1., 6. mesec, 0., 2., 6. mesec in 0., 6. mesec ter obnovitveni odmerek 4 leta po osnovnem cepljenju (Študija B1971033).
English: Do not mix Trumenba with other vaccines or medicinal products in the same syringe.
Slovenian: Cepiva Trumenba ne smemo mešati z drugimi cepivi ali zdravili v isti injekcijski brizgi.
English: % hSBA ≥ 1:8 Dose 2 344
Slovenian: % hSBA ≥ 1:8 2. odmerek 344
English: ≥ 4-Fold rise in hSBA titre (%) Dose 2 338
Slovenian: ≥ 4-kratno povečanje titra hSBA (%) 2. odmerek 338
English: % hSBA ≥ 1:8 Dose 2 353
Slovenian: % hSBA ≥ 1:8 2. odmerek 353
English: Immune Responses Among Individuals 10 to 25 Years of Age 1 Month Following the Third Dose of Trumenba or Control Given on a 0-, 2-, 6-Month Schedule (Study B1971009 and Study B1971016)
Slovenian: Imunski odzivi pri posameznikih, starih 10-25 let, 1 mesec po tretjem odmerku cepiva Trumenba ali kontrole po shemi 0., 2. in 6. mesec (Študija B1971009 in Študija B1971016) Študija B1971009 (starost 10-18 let)
English: ≥ 4-Fold rise in hSBA titre (%) Dose 2 341
Slovenian: ≥ 4-kratno povečanje titra hSBA (%) 2. odmerek 341
English: % hSBA ≥ 1:8 Dose 2 341
Slovenian: % hSBA ≥ 1:8 2. odmerek 341
English: PMB824 (A12) PMB1989 (A19)
Slovenian: PMB824 (A12)
English: ≥ 4-Fold rise in hSBA titre (%) Dose 2 339
Slovenian: ≥ 4-kratno povečanje titra hSBA (%) 2. odmerek 339
English: ≥ 4-Fold rise in hSBA titre (%) Dose 2 343
Slovenian: ≥ 4-kratno povečanje titra hSBA (%) 2. odmerek 343
English: Talk to your doctor, pharmacist or nurse before vaccination with Trumenba.
Slovenian: Pred cepljenjem s cepivom Trumenba se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Gastrointestinal disorders Very Common: Diarrhoea; nausea Common:
Slovenian: Bolezni imunskega sistema Neznana pogostnost: alergijske reakcije*
English: • have a weakened immune system which may prevent you or your child from getting the full benefit from Trumenba.
Slovenian: V tem primeru vam ali vašemu otroku cepivo Trumenba morda ne bo v celoti koristilo.
English: Group 3 (0, 1, and 6 Months) (0, 2, and 6 Months) (0 and 6 Months) GMT (95% CI)
Slovenian: (0. in 6. mesec) n GMT (95 % IZ) n GMT (95 % IZ) n GMT (95 % IZ)
English: Keep this medicine out of the sight and reach of children.
Slovenian: Cepivo shranjujte nedosegljivo otrokom!
English: Study B1971016 (10 to 18 Years of Age) (18 to 25 Years of Age)
Slovenian: (starost od 18 do 25 let)
English: hSBA Strain (fHbp Variant) Dose % hSBA ≥1:8
Slovenian: Odmerek % hSBA ≥ 1:8
English: Booster dose
Slovenian: Obnovitveni odmerek
English: • Changes in behaviour, especially in children.
Slovenian: • spremembe vedenja, posebno pri otrocih,
English: This generally occurs within the first year of treatment.
Slovenian: Ta se navadno pojavi v prvem letu zdravljenja.
English: Supportive and symptomatic treatment may be indicated.
Slovenian: Indicirano je lahko podporno in simptomatsko zdravljenje.
English: • Taste changes, such as an unpleasant taste in the mouth.
Slovenian: • spremembe okusa, npr. neprijeten okus v ustih,
English: If you forget to take a dose, take it as soon as you remember.
Slovenian: Če ste pozabili vzeti odmerek, ga vzemite takoj, ko se spomnite.
English: If you are to take a second inhalation, repeat steps 1 to 7.
Slovenian: Če morate narediti še drugi vdih, ponovite korake od 1 do 7.
English: • Depression.
Slovenian: • depresija,
English: Elderly patients (≥65 years old)
Slovenian: Starejši bolniki (≥ 65 let)
English: Caution with special diseases
Slovenian: Previdnost pri posebnih boleznih