natgillin/translations-raw huggingface dataset:
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to possible trace residues such as beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali na morebitne ostanke snovi v sledeh, kot so beta-propiolakton, cetiltrimetilamonijev bromid in polisorbat 80.
Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Vedno morata biti na voljo ustrezno zdravljenje in zdravstveni nadzor za primer redke anafilaktične reakcije po uporabi cepiva.
Children 9 to less than 18 years of age received a single dose of Flucelvax Tetra.
Otroci, stari od 9 let do manj kot 18 let, so prejeli en odmerek cepiva Flucelvax Tetra.
As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.
Kot pri vseh cepivih, tudi pri cepivu Flucelvax Tetra velja, da morda ne bo zagotovilo popolne zaščite vsem ljudem, ki so cepljeni.
Flucelvax Tetra has no or negligible influence on the ability to drive and use machines.
Cepivo Flucelvax Tetra nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Fever (≥ 38°C)
(≥38 °C)
Flucelvax Tetra provides active immunisation against four influenza virus strains (two A subtypes and two B types) contained in the vaccine.
Cepivo Flucelvax Tetra daje aktivno imunizacijo proti štirim sevom virusa gripe (dva podtipa A in dva podtipa B), ki jih vsebuje.
The preferred site for injection is the deltoid muscle of the upper arm.
Preferenčno mesto za injiciranje je deltoidna mišica nadlahti.
After shaking, the normal appearance of the vaccine is a clear to slightly opalescent suspension.
Normalen videz cepiva po pretresanju je bistra do rahlo opalescentna suspenzija.
V58P13 (Subjects 18 to < 50 years)
V58P13 (osebe, stare od 18 let do < 50 let)
A total of 11,404 subjects were enrolled to receive TIVc (N = 3828), Agrippal (N = 3676) or placebo (N = 3900) in a 1:1:1 ratio.
Skupno je bilo vključenih 11.404 oseb, ki so prejele cepivo TIVc (N = 3.828), cepivo Agrippal (N = 3.676) ali placebo (N = 3.900), in sicer v razmerju 1 : 1 : 1.
Table 5: GMTs and seroconversion rates in adult and paediatric subjects vaccinated with TIVc (V58P12 and V58P13)
Preglednica 5: GMT in stopnje serokonverzije pri odraslih in pediatričnih osebah, cepljenih s cepivom TIVc (V58P12 in V58P13)
Immune responses following vaccination with TIVc in the paediatric population (9 to < 18 years) were similar to those observed in the adult population in study V58P13 (see Table 5) in whom efficacy was demonstrated (results on vaccine efficacy are presented in Table 3).
Imunski odzivi po cepljenju s cepivom TIVc pri pediatrični populaciji (od 9 let do < 18 let) so bili podobni tistim, ki so jih opazili pri odrasli populaciji v študiji V58P13 (glejte preglednico 5), pri kateri so dokazali učinkovitost (rezultati učinkovitosti cepiva so prikazani v preglednici 3).
There was no evidence that the addition of the second influenza B strain resulted in immune interference to other strains included in the vaccine.
Ni bilo dokazov, da bi dodatek drugega seva virusa gripe B povzročil imunsko interferenco z drugimi sevi, vključenimi v cepivo.
• Your doctor or nurse will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration.
PREDEN prejmete cepivo: • bosta zdravnik ali medicinska sestra zagotovila, da bosta na voljo ustrezno zdravljenje in zdravstveni nadzor za primer redke anafilaktične reakcije (zelo hude alergijske reakcije s simptomi, kot so težave pri dihanju, omotičnost, šibek in hiter srčni utrip ter kožni izpuščaj) po uporabi.
• Generalised skin reactions including itching, bumps on the skin or non-specific rash
• splošne kožne reakcije, vključno s srbenjem, bulami na koži ali neznačilnim izpuščajem.
Flucelvax Tetra injection Influenza vaccine 2019/2020 season
Flucelvax Tetra injekcija cepivo proti gripi sezona 2019/2020
Fever was common in adolescents and children.
Zvišana telesna temperatura je bila pri mladostnikih in otrocih pogosta.
The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2019/2020 season.
Cepivo je usmerjeno na štiri seve virusa gripe, skladno s priporočili Svetovne zdravstvene organizacije za sezono 2019/2020.
TIVc efficacy was defined as the prevention of culture-confirmed symptomatic influenza illness caused by viruses antigenically matched to those in the vaccine compared to placebo.
Učinkovitost cepiva TIVc je bila opredeljena kot preprečevanje s kulturo celic potrjene simptomatične gripe, ki jo povzročajo virusi, ki se antigensko ujemajo s tistimi v cepivu, v primerjavi s placebom.
In the paediatric population 4 to less than 6 years of age, the following additional solicited adverse reactions were reported: sleepiness (21%), irritability (19%) and change in eating habits (14%).
V okviru sistematičnega poročanja so pri pediatrični populaciji starosti od 4 leta do manj kot 6 let poročali o naslednjih dodatnih neželenih učinkih: zaspanost (21 %), razdražljivost (19 %) in sprememba prehranjevalnih navad (14 %).
Overall, the immunogenicity results were in line with those obtained in subjects older than 9 years of age and showed a similar immune response in subjects receiving Flucelvax Tetra as compared to those receiving a comparator TIVc.
Na splošno so se rezultati imunogenosti ujemali s tistimi, pridobljenimi pri osebah, starejših od 9 let, in so pokazali podoben imunski odziv pri osebah, ki so prejele cepivo Flucelvax Tetra, in osebah, ki so prejele primerjalno cepivo TIVc.
In children who received a second dose of Flucelvax Tetra or cell-based trivalent influenza vaccine, the incidence of adverse reactions following the second dose of vaccine was similar to that observed with the first dose in this clinical trial.
Pri otrocih, ki so prejeli drugi odmerek cepiva Flucelvax Tetra ali trivalentnega cepiva proti gripi na celični osnovi, je bila incidenca neželenih učinkov po drugem odmerku cepiva podobna tisti, ki so jo opazili po prvem odmerku v tem kliničnem preskušanju.
0.5 ml suspension in pre-filled syringes (type I glass), with a plunger stopper (bromobutyl rubber), with or without needle.
0,5 ml suspenzije v napolnjenih injekcijskih brizgah (steklo tipa I) z batnim zamaškom iz bromobutilne gume, z iglo ali brez nje.
Seroconversion Rateb a For H1N1, H3N2 and B1 influenza strains TIV1c data are presented, whereas for B2 influenza strain TIV2c data are presented.
Stopnja serokonverzijeb a Za seve gripe H1N1, H3N2 in B1 so prikazani podatki za TIV1c, za sev gripe B2 pa so prikazani podatki za TIV2c.
Bold- CHMP immunogenicity criteria met.
Krepki tisk - Izpolnjena merila imunogenosti CHMP.
As with all injectable vaccines, Flucelvax Tetra must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration.
Kot pri vseh cepivih, ki se injicirajo, je tudi pri cepivu Flucelvax Tetra potrebna previdnost, ko se ga daje osebam s trombocitopenijo ali motnjo hemostaze, saj lahko pride do krvavitve po intramuskularni aplikaciji.
The percentage of subjects with seroconversion or significant increase in HI antibody titre is >40%, the percentage of subjects achieving an HI titre ≥1:40 is >70%.
Odstotek oseb s serokonverzijo ali značilnim zvišanjem titra protiteles HI je > 40 %, odstotek oseb, ki so dosegle titer HI ≥ 1 : 40, je > 70 %.
What you need to know before you receive Flucelvax Tetra You should not receive Flucelvax Tetra:
Kaj morate vedeti, preden boste prejeli cepivo Flucelvax Tetra Ne smete prejeti cepiva Flucelvax Tetra,
Flucelvax Tetra is available in packs containing 1 pre filled syringe with needle or 10 prefilled syringes with or without needles.
Cepivo Flucelvax Tetra je na voljo v pakiranjih z 1 napolnjeno injekcijsko brizgo ali 10 napolnjenimi injekcijskimi brizgami z iglami ali brez njih.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free'.
To cepivo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
V58P12 (Subjects 9 to < 18 years)
V58P12 (osebe, stare od 9 let do < 18 let)
The incidence of some adverse reactions were considerably lower among subjects ≥ 65 years of age when compared to subjects 18 to < 65 years of age (see table below).
Incidenca nekaterih neželenih učinkov je bila pri osebah, starih 65 let ali več, znatno manjša kot pri osebah, starih od 18 let do manj kot 65 let (glejte spodnjo preglednico).
The available immunogenicity data in the paediatric population 4 to less than 9 years of age were obtained in trial V130_03.
Razpoložljivi podatki o imunogenosti za pediatrično populacijo starosti od 4 leta do manj kot 9 let so bili pridobljeni v preskušanju V130_03.
Do not use this vaccine after the expiry date which is stated on the label and carton after EXP.
Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
MedDRA System Organ class Very common
Organski sistem po MedDRA Zelo pogosti
Flucelvax Tetra may contain traces of beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80.
Cepivo Flucelvax Tetra lahko vsebuje sledi beta-propiolaktona, cetiltrimetilamonijevega bromida in polisorbata 80.
The immunogenicity data in subjects 9 to less than 18 years of age are summarised in Table 4.
Podatki o imunogenosti pri otrocih, starih od 9 let do manj kot 18 let, so povzeti v preglednici 4.
Prophylaxis of influenza in adults and children from 9 years of age.
Preprečevanje gripe pri odraslih in otrocih, starih 9 let ali več.
Table 4: GMTs and seroconversion rates (with 95% CI) in subjects 9 to <18 years of age, 3 weeks after vaccination with Flucelvax Tetra or TIV1c/TIV2c - Per Protocol Set (V130_03)
Preglednica 4: GMT in stopnje serokonverzije (95-% IZ) pri osebah, starih od 9 let do < 18 let, 3 tedne po cepljenju s cepivom Flucelvax Tetra ali TIV1c/TIV2c - nabor za analizo po protokolu (V130_03)
Children 4 to less than 9 years of age received one or two doses (separated by 4 weeks) of Flucelvax Tetra based on determination of the subject's prior influenza vaccination history.
Otroci, stari od 4 leta do manj kot 9 let, so prejeli en ali dva odmerka cepiva Flucelvax Tetra (v presledku 4 tednov), na osnovi ugotovljene zgodovine cepljenja proti gripi pri posamezniku.
The vaccine should be visually inspected for particulate matter and discoloration prior to administration.
Cepivo je treba pred dajanjem vizualno pregledati glede prisotnosti delcev in razbarvanja.
This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium free'.
To cepivo vsebuje manj kot 1 mmol (39 mg) kalija na odmerek, kar v bistvu pomeni "brez kalija".
Flucelvax Tetra is given to you by your doctor or nurse as an injection into the muscle at the top of the upper arm (deltoid muscle).
Cepivo Flucelvax Tetra vam zdravnik ali medicinska sestra injicira v mišico na vrhu nadlahti (deltoidno mišico).
EU/1/18/1326/001 10 pre filled syringes without needle EU/1/18/1326/002 1 pre filled syringe with needle EU/1/18/1326/003 10 pre filled syringes with needle
EU/1/18/1326/001 10 napolnjenih injekcijskih brizg brez igle EU/1/18/1326/002 1 napolnjena injekcijska brizga z iglo EU/1/18/1326/003 10 napolnjenih injekcijskih brizg z iglo
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Po vsakem cepljenju ali celo pred njim se lahko kot psihogeni odziv na injekcijsko iglo pojavi sinkopa
Frequency not known3
Neznana pogostnost3
This reaction may occur with Flucelvax Tetra as with all vaccines that are injected.
Do te reakcije lahko pride pri uporabi cepiva Flucelvax Tetra tako kot pri vseh cepivih, ki se injicirajo;
Vaccination should be postponed in patients with acute febrile illness until the fever is resolved.
Pri bolnikih z akutno febrilno boleznijo je treba cepljenje preložiti, dokler zvišana telesna temperatura ne izzveni.
Flucelvax Tetra contains sodium chloride and potassium chloride
Cepivo Flucelvax Tetra vsebuje natrijev klorid in kalijev klorid
Tell your doctor or nurse if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription or if you have recently received any other vaccine.
Obvestite zdravnika ali medicinsko sestro, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
The immunogenicity data with TIVc are relevant to the use of Flucelvax Tetra because both vaccines are manufactured using the same process and have overlapping compositions.
Podatki o imunogenosti za TIVc so relevantni za uporabo cepiva Flucelvax Tetra, saj sta obe cepivi izdelani z istim postopkom in se njuni sestavi prekrivata.
A multinational, randomised, observer-blinded, placebo-controlled trial (V58P13) was performed to assess clinical efficacy and safety of TIVc during the 2007-2008 influenza season in adults aged 18 to less than 50 years.
Izvedeno je bilo multinacionalno, randomizirano, za opazovalca slepo, s placebom nadzorovano preskušanje (V58P13) pri odraslih, starih od18 let do manj kot 50 let, za oceno klinične učinkovitosti in varnosti cepiva TIVc med sezono gripe 2007-2008.
Flucelvax Tetra is a suspension for injection in a pre-filled syringe (ready to use syringe).
Cepivo Flucelvax Tetra je suspenzija za injiciranje v napolnjeni injekcijski brizgi (brizgi, pripravljeni za uporabo).
No human fertility data are available.
Podatkov o učinkih na plodnost pri človeku ni.
Animal data, with cell-based trivalent influenza vaccine (TIVc), have not shown effects on female fertility.
Podatki za trivalentno cepivo proti gripi na celični osnovi (TIVc), pridobljeni na živalih, ne kažejo vplivov na plodnost samic.
It is unknown whether Flucelvax Tetra is excreted in human milk.
Ni znano, ali se cepivo Flucelvax Tetra izloča v materino mleko.
Age subgroup analyses in subjects 18 to less than 65 years of age and 65 years of age and above confirmed that HI antibody responses (GMT and differences in vaccine group seroconversion rates) met non-inferiority immunogenicity criteria 3 weeks following vaccination for all 4 influenza strains in both age groups.
65 let ali več, so potrdile, da so odzivi HI protiteles (GMT in razlike v stopnjah serokonverzije med skupinami cepljenja) izpolnili merila neinferiornosti imunogenosti 3 tedne po cepljenju za vse 4 seve virusa gripe v obeh starostnih skupinah.
Antibody against one influenza virus type or subtype confers limited or no protection against another.
Zaščita, ki jo protitelesa proti enemu tipu ali podtipu virusa gripe zagotavljajo pred drugimi (pod)tipi, je omejena ali je ni.
The efficacy experience with TIVc is relevant to Flucelvax Tetra because both vaccines are manufactured using the same process and have overlapping compositions.
Izkušnje z učinkovitostjo cepiva TIVc so relevantne za cepivo Flucelvax Tetra, saj sta obe cepivi izdelani z istim postopkom in se njuni sestavi prekrivata.
Flucelvax Tetra is used to prevent flu in adults and children from 9 years of age.
Cepivo Flucelvax Tetra se uporablja za preprečevanje gripe pri odraslih in otrocih, starih 9 let ali več.
The safety and efficacy of Flucelvax Tetra in children from birth to less than 9 years of age has not been established.
Varnost in učinkovitost cepiva Flucelvax Tetra pri otrocih, mlajših od 9 let, nista bili dokazani.
A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Idaho/07/2018) 15 micrograms HA** A/Kansas/14/2017 (H3N2) - like strain (A/Indiana/08/2018) 15 micrograms HA** B/Colorado/06/2017 - like strain (B/Iowa/06/2017) 15 micrograms HA** B/Phuket/3073/2013 - like strain (B/Singapore/INFTT-16-0610/2016) 15 micrograms HA** per 0.5 ml dose * propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
A/Brisbane/02/2018 (H1N1)pdm09 podoben sev (A/Idaho/07/2018) 15 mikrogramov HA** A/Kansas/14/2017 (H3N2) podoben sev (A/Indiana/08/2018) 15 mikrogramov HA** B/Colorado/06/2017 podoben sev (B/Iowa/06/2017) 15 mikrogramov HA** B/Phuket/3073/2013 podoben sev (B/Singapore/INFTT-16-0610/2016) 15 mikrogramov HA** na 0,5-mililitrski odmerek * razmnoženih v celicah pasjih ledvic Madin Darby Canine Kidney (MDCK; to je posebna kultura celic, v kateri gojijo virus gripe) ** hemaglutinina
There are limited data from the use of Flucelvax Tetra in pregnant women.
Podatki o uporabi cepiva Flucelvax Tetra pri nosečnicah so omejeni.
A single 0.5 ml dose.
Enkratni odmerek 0,5 ml.
Adverse reactions reported are listed according to the following frequency categories: Very common
Neželeni učinki so navedeni po naslednjih razredih pogostnosti: zelo pogosti (≥ 1/10); pogosti
Table 3: Comparative efficacy of TIVc versus placebo against culture-confirmed influenza by influenza viral subtype (V58P13)
Preglednica 3: Primerjalna učinkovitost cepiva TIVc proti s celično kulturo potrjeni gripi v primerjavi s placebom, po podtipih virusa gripe (V58P13)
Pack of 10 pre-filled syringes, with or without needles.
Pakiranje z 10 napolnjenimi injekcijskimi brizgami, z iglami ali brez njih
The most common (≥10%) adverse reactions reported in paediatric subjects of 9 to < 18 years of age were injection site pain (58%), headache (22%), erythema (19%), fatigue (18%), myalgia (16%), and induration (15%).
9 let do <18 let, so bili bolečina na mestu injiciranja (58 %), glavobol (22 %), eritem (19 %), utrujenost (18 %), mialgija (16 %) in zatrdlina (15 %).
Suspension for injection in pre-filled syringe 10 pre-filled syringes (0.5 ml) without needle 1 pre-filled syringe (0.5 ml) with needle 10 pre-filled syringes (0.5 ml) with needle
suspenzija za injiciranje v napolnjeni injekcijski brizgi 10 napolnjenih injekcijskih brizg (0,5 ml) brez igle 1 napolnjena injekcijska brizga (0,5 ml) z iglo 10 napolnjenih injekcijskih brizg (0,5 ml) z iglo
Flucelvax Tetra may be given at the same time as other vaccines.
Cepivo Flucelvax Tetra se lahko daje sočasno z drugimi cepivi.
The most commonly reported (≥10%) reactions in subjects who received Flucelvax Tetra were pain at the injection site (34%), headache (14%), fatigue (14%), myalgia (14%), erythema (13%) and induration (10%).
Neželeni učinki, o katerih so najpogosteje (≥ 10 %) poročali pri osebah, ki so prejele cepivo Flucelvax Tetra, so bili bolečina na mestu injiciranja (34 %), glavobol (14 %), utrujenost (14 %), mialgija
The vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2019/2020 season.
Cepivo je v skladu s priporočili Svetovne zdravstvene organizacije (SZO) (za severno poloblo) in priporočili EU za sezono 2019/2020.
GMT (95% CI)
GMT (95-% IZ)
Specific levels of haemagglutination inhibition (HI) antibody titres post-vaccination with inactivated influenza vaccine have not been correlated with protection from influenza virus.
Ni korelacije med specifičnimi ravnmi titrov protiteles za zaviranje hemaglutinacije (HI) po cepljenju z inaktiviranim cepivom proti gripi in zaščito pred virusom gripe.
The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:
Učinkovine so inaktivirani površinski antigeni virusa influence (hemaglutinin in nevraminidaza) naslednjih sevov*:
Flucelvax Tetra induces humoral antibodies against the haemagglutinins.
Cepivo Flucelvax Tetra inducira humoralna protitelesa proti hemaglutininom.
Nausea, Diarrhoea, Vomiting2
Bolezni prebavil navzea, diareja, bruhanje2
Vaccine Group Difference (95% CI)
Razlika med skupinami cepljenja (95-% IZ)
Vomiting was uncommon in the elderly
Bruhanje je bilo pri starejših občasno.
What Flucelvax Tetra is and what it is used for
Kaj je cepivo Flucelvax Tetra in za kaj ga uporabljamo
Uncommon (≥1/1,000 to
(≥ 1/1.000 do
• Injection site pain, reddening, hardening or swelling at the site of the injection
• bolečina na mestu injiciranja, rdečina, otrditev ali otekanje na mestu injiciranja,
Contents of the pack and other information What Flucelvax Tetra contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo Flucelvax Tetra
The antibody response to influenza B strains contained in Flucelvax Tetra was superior to the antibody response after vaccination with TIVc containing an influenza B strain from the alternate lineage.
Odziv protiteles na seva virusa gripe B, ki ju vsebuje cepivo Flucelvax Tetra, je bil superioren odzivu protiteles po cepljenju s cepivom TIVc, ki je vsebovalo sev virusa gripe B iz druge linije.
Similar rates of solicited local and systemic adverse reactions were reported in subjects who received Flucelvax Tetra and cell-based trivalent influenza vaccine comparator in this clinical trial.
V okviru sistematičnega poročanja so v tem kliničnem preskušanju poročali o podobnih stopnjah lokalnih in sistemskih neželenih učinkov pri osebah, ki so prejele cepivo Flucelvax Tetra, in osebah, ki so prejele primerjalno trivalentno cepivo proti gripi na celični osnovi.
All Culture-Confirmed Influenza Overall
Vsi s celično kulturo potrjeni primeri gripe
Posology Adults and children from 9 years of age:
Odrasli in otroci, stari 9 let ali več:
Clinical efficacy of cell-based trivalent influenza vaccine (TIVc) against culture-confirmed influenza in adults
Klinična učinkovitost trivalentnega cepiva proti gripi na celični osnovi (TIVc) proti gripi pri odraslih,
Sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev hidrogenfosfat dihidrat, kalijev dihidrogenfosfat in voda za injekcije.
Keep the pre filled syringe in the outer carton in order to protect from light.
Napolnjeno injekcijsko brizgo shranjujte v škatli za zagotovitev zaščite pred svetlobo.
Pack of 1 pre-filled syringe, with needle
Pakiranje z 1 napolnjeno injekcijsko brizgo, z iglo.
Flucelvax Tetra is a clear to slightly opalescent suspension.
Cepivo Flucelvax Tetra je bistra do rahlo motna suspenzija.
Suspension for injection in pre-filled syringe (injection).
suspenzija za injiciranje v napolnjeni injekcijski brizgi (injekcija) bistra do rahlo opalescentna tekočina
Other medicines and Flucelvax Tetra
Druga zdravila in cepivo Flucelvax Tetra
Vaccine efficacies against vaccine-matched influenza viral strains, against all influenza viral strains, and against individual influenza viral subtypes were calculated (Table 3).
Izračunali so učinkovitosti cepiv proti sevom virusa gripe, ki so se ujemali s tistimi v cepivih, in sicer proti vsem sevom virusa gripe in proti posameznim podtipom virusa gripe (preglednica 3).
In this study, subjects received Flucelvax Tetra (N = 1159) or one of the two formulations of comparator cell-based trivalent influenza vaccine (TIVc) [TIV1c (N = 593), or TIV2c (N = 580)].
Tetra (N = 1159) ali eno od dveh formulacij primerjalnega trivalentnega cepiva proti gripi na celični osnovi (TIVc) [TIV1c (N = 593) ali TIV2c (N = 580)].
• Numbness and tingling sensation
• otrplost in občutek mravljinčenja,
The vaccine must not be injected intravenously, subcutaneously or intradermally and must not be mixed with other vaccines in the same syringe.
Cepivo se ne sme injicirati intravensko, subkutano ali intradermalno.
Table 2: Noninferiority of Flucelvax Tetra relative to TIVc in adults 18 years of age and above - Per protocol analysis set (V130_01)
Preglednica 2: Neinferiornost cepiva Flucelvax Tetra v primerjavi s cepivom TIVc pri odraslih, starih 18 let ali več - nabor za analizo po protokolu (V130_01)
Flucelvax Tetra is prepared in cell cultures, and, therefore, is egg-free.
Cepivo Flucelvax Tetra se pripravlja v kulturah celic in ne vsebuje jajčnih beljakovin.
Flucelvax Tetra may be used during breast-feeding.
Cepivo Flucelvax Tetra se lahko uporablja med dojenjem.