natgillin/translations-raw huggingface dataset:
Fainting, feeling faint, or other stress-related reactions can occur as a response to any needle injection.
• omedlevica, občutek omotičnosti ali druge s stresom povezane reakcije se lahko pojavijo kot odziv na kakršnokoli injiciranje z iglo.
You or your child will receive 2 injections of the vaccine, the second injection is given 6 months after the first injection.
Vi ali vaš otrok boste prejeli 2 injekciji cepiva, pri čemer vam bodo drugo injekcijo dali 6 mesecev po prvi injekciji.
Study B1971033 is an open-label, follow-up study of subjects previously enrolled in a primary study, including Study B1971012.
Študija B1971033 je odprta, nadaljevalna študija preskušancev, ki so predhodno sodelovali v primarni študiji, vključno s Študijo B1971012.
These additional hSBAs support and extend the breadth of vaccine coverage demonstrated by the 4 representative primary strains (Tables 3 and 4).
Ti dodatni preskusi hSBA podpirajo in povečujejo širino pokritosti s cepivom, dokazano s 4 reprezentativni primarnimi sevi (preglednici 3 in 4).
As with any vaccine, vaccination with Trumenba may not protect all vaccine recipients.
Kot velja za vsa cepiva, tudi cepljenje s cepivom Trumenba morda ne bo zaščitilo vseh cepljenih oseb.
For the second and third doses, serum was obtained approximately 1 month after the second or third vaccination dose.
Pri drugem in tretjem odmerku so serum pridobili približno 1 mesec po drugem ali tretjem odmerku cepiva.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti cepiva ne smemo mešati z drugimi zdravili.
The safety profile presented is based on analysis of over 15,000 subjects (aged 10 years and older) who have been vaccinated with at least 1 dose of Trumenba in 11 completed clinical studies.
Predstavljeni varnostni profil temelji na analizi več kot 15.000 preskušancev (starih 10 let in več), ki so jih v 11 zaključenih kliničnih preskušanjih cepili z vsaj 1 odmerkom cepiva Trumenba.
Similar results were observed in Groups 2 and 3 as observed in Group 1.
V Skupinah 2 in 3 so opazili podobne rezultate kot v Skupini 1.
In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded (or stated) in the patient file.
Za izboljšanje sledljivosti bioloških zdravil je treba v bolnikovo kartoteko jasno zabeležiti (ali navesti) zaščiteno ime in številko serije uporabljenega cepiva.
One dose (0.5 ml) contains:
En odmerek (0,5 ml) vsebuje:
Note: The lower limit of quantitation is an hSBA titre = 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).
Opomba: spodnja meja določljivosti je titer hSBA = 1:16 za PMB80 (A22) in 1:8 za PMB2001 (A56), PMB2948 (B24) in PMB2707 (B44).
A survey of over 2,150 different invasive meningococcal serogroup B isolates collected from 2000-2014 in 7 European countries, the US and Canada demonstrated that over 91% of all meningococcal serogroup B isolates expressed sufficient levels of fHbp to be susceptible to bactericidal killing by vaccine-induced antibodies.
Raziskava, v kateri so zajeli preko 2.150 različnih invazivnih izolatov meningokokov serološke skupine B, zbranih v letih 2000-2014 v 7 evropskih državah, ZDA in Kanadi, je pokazala, da več kot 91 % vseh izolatov meningokokov serološke skupine B izraža zadostne ravni beljakovine fHbp, da so dovzetni za batericidno uničenje s pomočjo protiteles, ki jih izzove cepivo.
Trumenba should only be used during breast-feeding when the possible advantages outweigh the potential risks.
Cepivo Trumenba se lahko med dojenjem uporabi le, kadar morebitne koristi odtehtajo morebitna tveganja.
Trumenba will be given to you or your child by a doctor, pharmacist or nurse.
Cepivo Trumenba bo vam ali vašemu otroku dal zdravnik, farmacevt ali medicinska sestra.
You or your child may be given a booster.
Vi ali vaš otrok boste morda prejeli obnovitveni odmerek.
A total of 2,693 subjects received at least 1 dose of Trumenba and 897 received at least 1 dose of HAV vaccine/saline.
Skupno 2.693 preskušancev je prejelo vsaj 1 odmerek cepiva Trumenba, 897 pa jih je prejelo vsaj en odmerek cepiva HAV/fiziološke raztopine.
Procedures should be in place to avoid injury from fainting.
Pomembno je zagotoviti ukrepe za preprečitev poškodb v primeru omedlevice.
Trumenba contains sodium This medicinal product contains less than 23 mg sodium per dose, i.e. essentially ‘sodium-free'.
Cepivo Trumenba vsebuje natrij To cepivo vsebuje manj kot 23 mg natrija na odmerek, kar v bistvu pomeni ''brez natrija''.
Other medicines and Trumenba
Druga zdravila in cepivo Trumenba
Do not inject intravenously, intradermally, or subcutaneously.
Ne injicirajte intravensko, intradermalno ali subkutano.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovine ali katerokoli pomožno snov, navedeno v poglavju 6.1.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Neuporabljeno cepivo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
• have a bleeding problem or bruise easily.
• imate težave s strjevanjem krvi ali se vam hitro pojavijo podplutbe.
Persons with familial complement deficiencies (for example, C5 or C3 deficiencies) and persons receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroup B, even if they develop antibodies following vaccination with Trumenba.
Pri osebah s familiarnimi pomanjkanji komplementa (na primer pomanjkanja C5 ali C3) in osebah, ki prejemajo zdravljenje, ki zavira aktivacijo terminalnega komplementa (na primer ekulizumab), obstaja povečano tveganje za invazivno bolezen, ki jo povzroča Neisseria meningitidis serološke skupine B, tudi če po cepljenju s cepivom Trumenba razvijejo protitelesa.
Administration of Trumenba with vaccines other than those mentioned above, has not been studied.
Dajanja cepiva Trumenba skupaj s cepivi, ki niso navedena zgoraj, niso preučevali.
Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Vedno morata biti na voljo ustrezna medicinska oskrba in nadzor za primer, da se po dajanju cepiva pojavi anafilaktična reakcija.
During storage, a white deposit and clear supernatant may be observed.
Med shranjevanjem lahko nastaneta bela usedlina in bister supernatant.
The tip cap and rubber plunger of the pre-filled syringe are not made with natural rubber latex.
Zaporka konice brizge in gumijasti bat napolnjene injekcijske brizge nista izdelana iz gume iz naravnega lateksa.
Trumenba 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.
Cepiva Trumenba ne smemo uporabiti pri posameznikih s trombocitopenijo ali katerokoli motnjo strjevanja krvi, pri kateri je intramuskularno injiciranje kontraindicirano, razen če morebitna korist jasno odtehta tveganje uporabe.
EU/1/17/1187/001 - pack of 1 with separate needle EU/1/17/1187/002 - pack of 1 without needle EU/1/17/1187/003 - pack of 5 with separate needles EU/1/17/1187/004 - pack of 5 without needles EU/1/17/1187/005 - pack of 10 with separate needles EU/1/17/1187/006 - pack of 10 without needles
EU/1/17/1187/001 - pakiranje po 1 s priloženo iglo EU/1/17/1187/002 - pakiranje po 1 brez igle EU/1/17/1187/003 - pakiranje po 5 s priloženimi iglami EU/1/17/1187/004 - pakiranje po 5 brez igel EU/1/17/1187/005 - pakiranje po 10 s priloženimi iglami EU/1/17/1187/006 - pakiranje po 10 brez igel
3 doses: 2 doses (0.5 ml each) administered at least 1 month apart, followed by a third dose at least 4 months after the second dose (see section 5.1).
3 odmerki: 2 odmerka (vsak po 0,5 ml) dana v razmiku vsaj 1 meseca, čemur sledi tretji odmerek vsaj 4 mesece po drugem odmerku (glejte poglavje 5.1).
fHbp is found on the surface of meningococcal bacteria and is essential for bacteria to avoid host immune defenses.
Beljakovina fHbp se nahaja na površini meningokoknih bakterij in je nujna, da se lahko bakterije izognejo obrambi gostiteljevega imunskega sistema.
In the immunogenicity analysis for Trumenba, a response was defined as an hSBA titre of at least 1:8 or 1:16 depending on the hSBA strain.
V analizi imunogenosti za cepivo Trumenba je bil odziv opredeljen kot titer hSBA, ki je vsaj 1:8 ali 1:16, odvisno od seva, uporabljenega v hSBA.
• Official batch release
• Uradna sprostitev serije
Adverse reactions following booster vaccination in 268 subjects aged 15 to 23 years were similar to adverse reactions during the primary Trumenba vaccination series approximately 4 years earlier.
Neželeni učinki po obnovitvenem cepljenju pri 268 preskušancih, starih od 15 do 23 let, so bili podobni neželenim učinkom med osnovno shemo cepljenja s cepivom Trumenba približno 4 leta pred tem.
You or your child will receive 2 injections of the vaccine given at least 1 month apart and a third injection at least 4 months after the second injection.
Vi ali vaš otrok boste prejeli 2 injekciji cepiva, dani v presledku vsaj 1 meseca, ter tretjo injekcijo vsaj 4 mesece po drugi injekciji.
What Trumenba is and what it is used for
Kaj je cepivo Trumenba in za kaj ga uporabljamo
Suspension for injection
suspenzija za injiciranje
Study B1971016 (18-25 years of age)
Študija B1971016 (starost 18-25 let)
Before use, the pre-filled syringe should be shaken vigorously to ensure that a homogeneous white suspension is obtained.
Pred uporabo je treba napolnjeno injekcijsko brizgo dobro pretresti, da zagotovimo nastanek homogene bele suspenzije.
Tell your doctor, pharmacist or nurse if you or your child:
Obvestite zdravnika, farmacevta ali medicinsko sestro, če za vas ali vašega otroka velja, da:
Do not throw away any medicines via wastewater or household waste.
Cepiva ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
The most common adverse reactions observed were injection site pain, redness and swelling at the vaccination site, headache, fatigue, chills, diarrhoea, muscle pain, joint pain, and nausea.
Najpogosteje opaženi neželeni učinki so bili bolečina na mestu injiciranja, pordelost in oteklina na mestu cepljenja, glavobol, utrujenost, mrzlica, diareja, bolečina v mišicah, bolečina v sklepih in navzea.
A 4-fold increase in hSBA titre for each of the 4 primary meningococcal serogroup B test strains was defined as follows: (1) For subjects with a baseline hSBA titre < 1:4, a 4-fold response was defined as an hSBA titre ≥ 1:16.
Štirikraten porast titra hSBA za vsakega od 4 primarnih testnih sevov meningokokov serološke skupine B so opredelili kot: (1) pri preskušancih s titrom hSBA < 1:4 ob izhodišču je bil 4-kratni odziv opredeljen kot titer hSBA ≥ 1:16.
BATCH NUMBER<, DONATION AND PRODUCT CODES>
ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV
The European Medicines Agency has deferred the obligation to submit the results of studies with Trumenba in one or more subsets of the paediatric population for prevention of invasive meningococcal disease caused by N. meningitidis serogroup B (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s cepivom Trumenba za eno ali več podskupin pediatrične populacije za preprečevanje invazivne meningokokne bolezni, ki jo povzroča N. meningitidis serološke skupine B (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Tell your doctor, pharmacist or nurse if you have experienced this kind of reaction previously.
Zdravniku, farmacevtu ali medicinski sestri povejte, če ste vi ali vaš otrok v preteklosti že kdaj doživeli tovrstno reakcijo.
1 dose (0.5 ml)
En odmerek (0,5 ml)
1 single-dose (0.5 ml) pre-filled syringe with needle 1 single-dose (0.5 ml) pre-filled syringe without needle 5 single-dose (0.5 ml) pre-filled syringes with needles 5 single-dose (0.5 ml) pre-filled syringes without needles 10 single-dose (0.5 ml) pre-filled syringes with needles 10 single-dose (0.5 ml) pre-filled syringes without needles
1 enoodmerna (0,5 ml) napolnjena injekcijska brizga z iglo 1 enoodmerna (0,5 ml) napolnjena injekcijska brizga brez igle 5 enoodmernih (0,5 ml) napolnjenih injekcijskih brizg z iglami 5 enoodmernih (0,5 ml) napolnjenih injekcijskih brizg brez igel 10 enoodmernih (0,5 ml) napolnjenih injekcijskih brizg z iglami 10 enoodmernih (0,5 ml) napolnjenih injekcijskih brizg brez igel
The efficacy of Trumenba has not been evaluated through clinical trials.
Učinkovitosti cepiva Trumenba v kliničnih preskušanjih niso ovrednotili.
Very common (these may affect more than 1 in 10 people) - Redness, swelling and pain at injection site - Headache - Diarrhoea - Nausea - Muscle pain - Joint pain - Chills - Fatigue
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 oseb) - pordelost, oteklina in bolečina na mestu injiciranja - glavobol - driska - občutek siljenja na bruhanje - bolečina v mišicah - bolečina v sklepih - mrzlica - utrujenost
* The following is considered an adverse reaction for Trumenba and was reported in the postmarketing experience.
* Velja za neželeni učinek cepiva Trumenba, o njem pa so poročali v obdobju trženja cepiva.
0.5 ml suspension in a pre-filled syringe (Type I glass) with plastic Luer Lok adapter, chlorobutyl rubber plunger stopper, and a synthetic isoprene bromobutyl rubber tip cap with a plastic rigid tip cap cover with or without needle.
0,5 ml suspenzija v napolnjeni injekcijski brizgi (steklo tipa I) s plastičnim nastavkom Luer lock, batnim zamaškom iz klorobutilne gume in zaporko konice brizge iz sintetične izopren-bromobutilne gume s togim plastičnim pokrovčkom, z iglo ali brez nje.
(2) For subjects with a baseline hSBA titre ≥ 1:4, a 4-fold response was defined as an hSBA titre ≥ 4 times the lower limit of quantitation or ≥ 4 times the baseline titre, whichever was higher.
(2) Pri preskušancih s titrom hSBA ≥ 1:4 ob izhodišču je bil 4-kratni odziv opredeljen kot titer hSBA, ki je ≥ 4-kratniku spodnje meje določljivosti ali ≥ 4-kratniku titra ob izhodišču; kateri je večji.
total of 2,471 subjects received Trumenba and 822 received saline.
Skupno 2.471 preskušancev je prejelo cepivo Trumenba, 822 pa jih je prejelo fiziološko raztopino.
48 Months after last primary Dose
48 mesecev po zadnjem osnovnem odmerku
Dose 3 1170
3. odmerek 1.170
What you need to know before you or your child receives Trumenba
Kaj morate vedeti, preden boste vi ali vaš otrok prejeli cepivo Trumenba
The study assessed the safety, tolerability, immunogenicity, and demonstration of manufacturability of 3 lots of Trumenba administered on a 0-, 2-, and 6-month schedule.
V študiji so ocenjevali varnost, prenašanje, imunogenost in prikaz procesibilnosti 3 serij cepiva Trumenba, danega po shemi cepljenja v 0., 2. in 6. mesecu.
There are no data from the use of Trumenba in pregnant women.
Podatkov o uporabi cepiva Trumenba pri nosečnicah ni.
As with other injectable vaccines, syncope (fainting) can occur in association with administration of Trumenba.
Kot pri drugih cepivih za injiciranje, se lahko tudi v povezavi s cepljenjem s cepivom Trumenba pojavi sinkopa (omedlevica).
Trumenba is a vaccine composed of 2 recombinant lipidated factor H binding protein (fHbp) variants.
Cepivo Trumenba je sestavljeno iz 2 variant rekombinantne lipidirane faktor H-vezavne beljakovine (fHbp).
The 4 test strains express fHbP variants representing the 2 subfamilies (A and B) and, when taken together, are representative of meningococcal serogroup B strains causing invasive disease.
Ti 4 testni sevi izražajo variante beljakovine fHbp iz 2 podskupin (A in B), ko jih združimo, pa so reprezentativni za seve meningokokov serološke skupine B, ki povzročajo invazivno bolezen.
There are no data available on the interchangeability of Trumenba with other meningococcal group B vaccines to complete the vaccination series.
Podatki o zamenljivosti cepiva Trumenba z drugimi cepivi proti meningokokom skupine B za dokončanje sheme cepljenja niso na voljo.
Trumenba has no or negligible influence on the ability to drive and use machines.
Cepivo Trumenba nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
It is unknown whether Trumenba is excreted in human milk.
Ni znano, ali se cepivo Trumenba izloča v materino mleko.
The preferred site for injection is the deltoid muscle of the upper arm.
Priporočeno mesto injiciranja je deltoidna mišica nadlakti.
Recombinant lipidated fHbp (factor H binding protein) Produced in Escherichia coli cells by recombinant DNA technology Adsorbed on aluminium phosphate (0.25 milligram aluminium per dose)
60 mikrogramov rekombinantna lipidirana beljakovina fHbp (factor H binding protein - faktor H-vezavna beljakovina) izdelano v celicah Escherichia coli s tehnologijo rekombinantne DNK adsorbirano na aluminijev fosfat (0,25 miligramov aluminija na odmerek)
It will be injected into the upper arm muscle.
Cepivo bodo injicirali v mišico na nadlakti.
For intramuscular injection only.
Samo za intramuskularno injiciranje.
When Trumenba is given to your or your child, the following side effects may occur:
Ko boste vi ali vaš otrok prejeli cepivo Trumenba, se lahko pojavijo naslednji neželeni učinki:
Driving and using machines Trumenba has no or little influence on the ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Cepivo Trumenba nima vpliva ali ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Sodium chloride, histidine, water for injections, aluminium phosphate and polysorbate 80 (E433).
natrijev klorid, histidin, voda za injekcije, aluminijev fosfat in polisorbat 80 (E433)
Dose 2 308
odmerek 308
fHbp variants segregate into 2 immunologically distinct subfamilies, A and B, and over 96% of meningococcal serogroup B isolates in Europe express fHbp variants from either subfamily on the bacterial surface.
Variante beljakovine fHbp delimo na 2 imunološko različni podskupini A in B, pri čemer ima več kot 96 % izolatov meningokokov serološke skupine B v Evropi na površini bakterij izražene variante fHbp iz ene ali druge podskupine.
Ask your pharmacist how to throw away medicines you no longer use.
O načinu odstranjevanja cepiva, ki ga ne uporabljate več, se posvetujte s farmacevtom.
Protection against invasive meningococcal disease is mediated by serum bactericidal antibodies to bacterial surface antigens.
Zaščito pred invazivno meningokokno boleznijo posredujejo serumska baktericidna protitelesa proti antigenom na površini bakterij.
What Trumenba looks like and contents of the pack
Izgled cepiva Trumenba in vsebina pakiranja
The presence of a minor infection, such as a cold, should not require postponement of the vaccination,
Blaga okužba, npr. prehlad, pa ni razlog za odložitev cepljenja.
In the event of any foreign particulate matter and/or variation of physical aspect being observed, do not administer the vaccine.
Če opazite kakršnekoli vidne delce in/ali spremembo izgleda, cepiva ne smete uporabiti.
Shake well prior to use to obtain a homogeneous white suspension.
Pred uporabo dobro pretresite, da nastane homogena bela suspenzija.
Trumenba is for intramuscular use only.
Cepivo Trumenba je samo za intramuskularno uporabo.
Sodium chloride, histidine, water for injections, and polysorbate 80 (E433).
natrijev klorid, histidin, voda za injekcije in polisorbat 80 (E433).
12 Months after last primary Dose
12 mesecev po zadnjem osnovnem odmerku
Primary series 2 doses (0.5 ml each) administered at a 6 month interval (see section 5.1).
Osnovna shema 2 odmerka (vsak po 0,5 ml) dana v razmiku 6 mesecev (glejte poglavje 5.1).
In Study B1971012, Trumenba was administered according to the following schedules: Group 1 (0, 1, and 6 months); Group 2 (0, 2, and 6 months); Group 3 (0 and 6 months); Group 4 (0 and 2 months); Group 5 (0 and 4 months).
V Študiji B1971012 so cepivo Trumenba dajali skladno z naslednjimi shemami: Skupina 1 (0., 1. in 6. mesec), Skupina 2 (0., 2. in 6. mesec), Skupina 3 (0. in 6. mesec), Skupina 4 (0. in 2. mesec) in Skupina 5 (0. in 4. mesec).
There are no data on the use of Trumenba in subjects above 65 years of age.
Podatkov o uporabi cepiva Trumenba pri preskušancih, starejših od 65 let, ni na voljo.
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.
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).
1 Month after last primary Dose
1 mesec po zadnjem osnovnem odmerku
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).
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).
Manufacturer responsible for batch release: Pfizer Manufacturing Belgium N.V. Rijksweg 12
Izdelovalec, odgovoren za sproščanje serij: Pfizer Manufacturing Belgium N.V.
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).
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).
Trumenba is indicated for active immunisation of individuals 10 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.
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.
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.
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.
It is important to follow the instructions from the doctor, pharmacist or nurse so that you or your child completes the course of injections.
Pomembno je, da upoštevate navodila zdravnika, farmacevta ali medicinske sestre in da vi oziroma vaš otrok prejmete vse predvidene odmerke.
All subjects received 4 study injections, either 2 or 3 doses of Trumenba and 1 or 2 doses of saline.
Vsi preskušanci so v preskušanju prejeli 4 injekcije, in sicer 2 oziroma 3 odmerke cepiva Trumenba in 1 oziroma 2 odmerka fiziološke raztopine.
A composite response was defined as a response for all 4 hSBA strains combined.
Sestavljeni odziv so opredelili kot porast pri vseh 4 sevih v hSBA skupaj.
Composite response (A response for all 4 hSBA strains combined) 1 Month after last primary Dose
Sestavljeni odziv (odziv pri vseh 4 sevih v hSBA skupaj) 1 mesec po zadnjem osnovnem odmerku
Reproduction studies performed in female rabbits have revealed no evidence of impaired female fertility or harm to the foetus due to Trumenba.
Študije vpliva na sposobnost razmnoževanja pri kunčjih samicah niso pokazale zmanjšane plodnosti samic zaradi cepiva Trumenba ali škodljivih učinkov tega cepiva na plod.
See section 5.1 for information on the immune response against specific serogroup B strains.
Za informacije o imunskem odzivu na specifične seve serološke skupine B glejte poglavje 5.1.