natgillin/translations-raw huggingface dataset:
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.
Multinacionalno, randomizirano, placebom kontrolirano ispitivanje (V58P13) sa zaslijepljenim promatračem provedeno je radi utvrđivanja kliničke djelotvornosti i sigurnosti cjepiva TIVc tijekom sezone influence 2007.-2008. u odraslih u dobi od 18 do < 50 godina.
* propagated in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in which the influenza virus is grown); ** haemagglutinin
* umnoženi u psećim bubrežnim stanicama Madin Darby (MDCK) (to je specijalna stanična kultura u kojoj se uzgaja virus influence) ** hemaglutinin
The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2019/2020 season.
Cjepivo je usmjereno protiv četiri soja virusa influence u skladu s preporukama Svjetske zdravstvene organizacije za sezonu 2019/2020.
V58P12 (Subjects 9 to < 18 years)
V58P12 (Ispitanici u dobi 9 do < 18 godina)
Table 5: GMTs and seroconversion rates in adult and paediatric subjects vaccinated with TIVc (V58P12 and V58P13)
Tablica 5: GMT i stope serokonverzije u odraslih i pedijatrijskih ispitanika cijepljenih cjepivom TIVc (V58P12 i V58P13)
• Generalised skin reactions including itching, bumps on the skin or non-specific rash
• generalizirane kožne reakcije uključujući svrbež, kvržice na koži ili nespecifični osip
(≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100), not known (cannot be estimated from the available data).
(≥ 1/100 do < 1/10); manje često (≥ 1/1000 do < 1/100).
Vomiting was uncommon in the elderly
Povraćanje je bilo manje često u starijih.
The safety and efficacy of Flucelvax Tetra in children from birth to less than 9 years of age has not been established.
Sigurnost i djelotvornost cjepiva Flucelvax Tetra u djece u dobi od rođenja do najviše 9 godina nisu ustanovljene.
Seroconversion Ratea 56% (48%-65%)
Stopa serokonverzijea 56% (48%-65%)
In the event of any foreign particulate matter and/or variation of physical aspect is observed, do not administer the vaccine.
U slučaju prisutnosti stranih čestica i/ili promjene fizikalnih značajki, cjepivo se ne smije primijeniti.
This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2019/2020 season.
Ovo cjepivo odgovara preporuci (sjeverna hemisfera) Svjetske zdravstvene organizacije (SZO) i preporuci EU-a za sezonu 2019/2020.
Number of Subjects with Influenza
Broj ispitanika s influencom
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.
Kao i sva cjepiva koja se ubrizgavaju, Flucelvax Tetra mora se primjenjivati s oprezom u pojedinaca s trombocitopenijom ili poremećajima krvarenja, budući da krvarenje može nastupiti nakon intramuskularne primjene.
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%).
Najčešće zabilježene nuspojave (≥ 10%) u onih koji su primili Flucelvax Tetra bile su bol na mjestu injekcije (34%), glavobolja (14%), umor (14%), mialgija (14%), eritem (13%) i induracija (10%).
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.
Preosjetljivost na djelatnu tvar, neku od pomoćnih tvari navedenih u dijelu 6.1 ili na moguće ostatke u tragovima poput beta-propiolaktona, cetiltrimetilamonijevog bromida ili polisorbata 80.
There was no evidence that the addition of the second influenza B strain resulted in immune interference to other strains included in the vaccine.
Nije bilo dokaza da je dodavanje drugog soja virusa influence B rezultiralo imunološkom interferencijom s drugim sojevima uključenima u cjepivo.
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%).
pedijatrijskoj populaciji u dobi od 4 do < 6 godina, zabilježene su dodatne izazvane nuspojave: pospanost (21%), razdražljivost (19%) i promjena prehrambenih navika (14%).
Antibody against one influenza virus type or subtype confers limited or no protection against another.
Protutijela protiv jednog tipa ili podtipa virusa influence nude ograničenu ili nikakvu zaštitu od drugih tipova i podtipova.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient to prevent influenza.
Odgovor protutijela u bolesnika s endogenom ili jatrogenom imunosupresijom može biti nedostatan u sprječavanju influence.
• Nausea, vomiting, diarrhoea
• mučnina, povraćanje, proljev
This reaction may occur with Flucelvax Tetra as with all vaccines that are injected.
Ta se reakcija može dogoditi s cjepivom Flucelvax Tetra kao i sa svim cjepivima koja se daju injekcijom.
Adverse reactions reported are listed according to the following frequency categories: Very common
Tablični prikaz nuspojava Prijavljene nuspojave navedene su prema sljedećim kategorijama učestalosti: vrlo često (≥ 1/10); često
Flucelvax Tetra may contain traces of beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80.
Flucelvax Tetra može sadržavati tragove beta-propiolaktona, cetiltrimetilamonijevog bromida i polisorbata 80.
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
soju A/Brisbane/02/2018 (H1N1)pdm09 sličan soj (A/Idaho/07/2018) 15 mikrograma HA** soju A/Kansas/14/2017 (H3N2) sličan soj (A/Indiana/08/2018) 15 mikrograma HA** soju B/Colorado/06/2017 sličan soj (B/Iowa/06/2017) 15 mikrograma HA** soju B/Phuket/3073/2013 sličan soj (B/Singapore/INFTT-16-0610/2016) 15 mikrograma HA** po dozi od 0,5 ml * umnoženi u psećim bubrežnim stanicama Madin Darby (engl.
Flucelvax Tetra contains sodium chloride and potassium chloride
Flucelvax Tetra sadrži natrijev klorid i kalijev klorid
Flucelvax Tetra is a vaccine against flu (influenza).
Flucelvax Tetra je cjepivo protiv gripe (influence).
Reproductive and developmental toxicology data from cell-based trivalent influenza vaccine (TIVc) do not predict an increased risk of developmental abnormalities.
Podaci o reproduktivnoj i razvojnoj toksičnosti trovalentnog cjepiva protiv influence dobivenog iz stanične kulture (TIVc) ne predviđaju povećani rizik za nastanak razvojnih poremećaja.
What you need to know before you receive Flucelvax Tetra You should not receive Flucelvax Tetra:
Što morate znati prije nego primite Flucelvax Tetra Flucelvax Tetra ne smijete primiti:
Clear to slightly opalescent liquid.
Bistra do blago opalescentna tekućina.
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 u napunjenim štrcaljkama (staklo tipa I) s čepom klipa (brombutilna guma) sa ili bez igle.
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.
Općenito, rezultati koji se odnose na imunogenost sukladni su onima dobivenim za ispitanike starije od 9 godina i pokazuju sličan imunosni odgovor u ispitanika cijepljenih cjepivom Flucelvax Tetra u usporedbi s ispitanicima cijepljenima usporednim cjepivom TIVc.
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.
Djeca u dobi od 4 do < 9 godina primili su jednu ili dvije doze cjepiva Flucelvax Tetra (u razmaku od 4 tjedna), ovisno o tome jesu li nekad ranije bili cijepljeni cjepivom protiv influence.
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 napunjenih štrcaljki bez igle EU/1/18/1326/002 1 napunjena štrcaljka s iglom EU/1/18/1326/003 10 napunjenih štrcaljki s iglom
This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium free'.
Ovo cjepivo sadrži kalij, manje od 1 mmol (39 mg) po dozi, tj. zanemarive količine kalija.
Specific levels of haemagglutination inhibition (HI) antibody titres post-vaccination with inactivated influenza vaccine have not been correlated with protection from influenza virus.
Specifične razine titra protutijela koja inhibiraju hemaglutinaciju (HI) nakon cijepljenja inaktiviranim cjepivom protiv influence nisu povezane sa zaštitom od virusa influence.
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)].
U tom ispitivanju ispitanici su primili Flucelvax Tetra (N=1159) ili jedan od dvije kontrolne formulacije trovalentnog cjepiva protiv influenze dobivenog iz kulture stanica (TIVc) [TIV1c (N=593), ili TIV2c (N=580)].
Flucelvax Tetra was non-inferior to TIVc.
Cjepivo Flucelvax Tetra nije bilo inferiorno prema TIVc.
Paediatric Population (4 to less than 9 years of age)
Pedijatrijska populacija (od 4 do < 9 godina)
Siena Tel: +39 0577 096400
Seqirus S.r.l. Siena Tel: +39 0577 096400
Flucelvax Tetra is available in packs containing 1 pre filled syringe with needle or 10 prefilled syringes with or without needles.
Flucelvax Tetra je dostupan u pakiranjima koja sadrže 1 napunjenu štrcaljku (0,5 ml) s iglom ili 10 napunjenih štrcaljki sa ili bez igle.
Table 1: Adverse reactions reported following vaccination in adults 18 years and older in clinical trials and post-marketing surveilance.
Tablica 1: Nuspojave zabilježene nakon cijepljenja odraslih u dobi od 18 godina i starijih, u kliničkim ispitivanjima i tijekom praćenja nakon davanja odobrenja za stavljanje cjepiva u promet
Posology Adults and children from 9 years of age:
Odrasli i djeca od navršenih 9 godina nadalje:
Paediatric population (9 to less than 18 years of age)
Pedijatrijska populacija (od 9 do < 18 godina)
Vaccine efficacies against vaccine-matched influenza viral strains, against all influenza viral strains, and against individual influenza viral subtypes were calculated (Table 3).
Izračunata je djelotvornost cjepiva protiv sojeva virusa iz cjepiva, protiv svih sojeva virusa influence i protiv individualnih podtipova virusa (tablica 3).
• Numbness and tingling sensation
• utrnulost i osjećaj trnaca
The immune response to each of the vaccine antigens was assessed 21 days after vaccination.
Imunološki odgovor na svaki od antigena cjepiva procijenjen je 21 dan nakon cijepljenja.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free'.
Ovo cjepivo sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
Flucelvax Tetra is a suspension for injection in a pre-filled syringe (ready to use syringe).
Flucelvax Tetra je suspenzija za injekciju u napunjenoj štrcaljki (štrcaljka spremna za uporabu).
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%).
Najčešće (≥ 10%) nuspojave zabilježene u pedijatrijskih ispitanika u dobi od 9 do < 18 godina bile su bol na mjestu injekcije (58%), glavobolja (22%), eritem (19%), umor (18%), mialgija (16%) i induracija (15%).
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.
Djelotvornost cjepiva TIVc definirana je kao sprječavanje simptomatske influence potvrđene staničnom kulturom uzrokovane virusima koju su antigenski odgovarali onima u cjepivu, a u usporedbi s placebom.
A single 0.5 ml dose.
Jedna doza od 0,5 ml
GMT (95% CI) Seroconversion Ratea 77% (70%-84%)
GMT (95% CI) Stopa serokonverzijea 77% (70%-84%)
Based on clinical experience with cell-based trivalent influenza vaccine (TIVc), Flucelvax Tetra can be given at the same time as other vaccines.
Na temelju kliničkog iskustva s trovalentnim cjepivom protiv influence dobivenim iz stanične kulture (engl. cell culture-derived trivalent influenza vaccine, TIVc), Flucelvax Tetra se može primijeniti istodobno s drugim cjepivima.
What Flucelvax Tetra is and what it is used for
Što je Flucelvax Tetra i za što se koristi
Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:
Površinski antigeni virusa influence (hemaglutinin i neuraminidaza), inaktivirani, sljedećih sojeva*:
Ελλάδα
Ολλανδία
Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane gubitak apetita
The efficacy experience with TIVc is relevant to Flucelvax Tetra because both vaccines are manufactured using the same process and have overlapping compositions.
Iskustvo s djelotvornošću cjepiva TIVc relevantno je za cjepivo Flucelvax Tetra jer su oba cjepiva proizvedena korištenjem istog postupka i sadrže komponente koje se podudaraju.
Flucelvax Tetra has no or negligible effect on your ability to drive and use machines.
Flucelvax Tetra ne utječe ili zanemarivo utječe na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
What Flucelvax Tetra looks like and contents of the pack
Kako Flucelvax Tetra izgleda i sadržaj pakiranja
Flucelvax Tetra injection Influenza vaccine 2019/2020 season
Flucelvax Tetra injekcija cjepivo protiv influence sezona 2019/2020.
Nervous system disorders
Poremećaji živčanog sustava glavobolja1
Clinical efficacy of cell-based trivalent influenza vaccine (TIVc) against culture-confirmed influenza in adults
Klinička djelotvornost trovalentnog cjepiva protiv influence dobivenog iz stanične kulture(TIVc) protiv influence u odraslih dokazana na kulturi stanica
Flucelvax Tetra is used to prevent flu in adults and children from 9 years of age.
Flucelvax Tetra se upotrebljava za sprječavanje gripe u odraslih i djece od navršenih 9 godina nadalje.
• Injection site pain, reddening, hardening or swelling at the site of the injection
• bol na mjestu injekcije, crvenilo, otvrdnuće ili oticanje na mjestu injekcije
It is unknown whether Flucelvax Tetra is excreted in human milk.
Nije poznato izlučuje li se Flucelvax Tetra u majčino mlijeko.
Other medicines and Flucelvax Tetra
Drugi lijekovi i Flucelvax Tetra
In this study, 1159 paediatric subjects received Flucelvax Tetra (584 subjects aged > 9 to < 18 years; 575 subjects aged > 4 to < 9 years).
Djeca u dobi od 9 do < 18 godina primila su jednu dozu cjepiva Flucelvax Tetra (584 ispitanika u dobi > 9 do < 18 godina; 575 ispitanika u dobi > 4 do < 9 godina).
Flucelvax Tetra has no or negligible influence on the ability to drive and use machines.
Flucelvax Tetra ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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 injekciju u napunjenoj štrcaljki 10 napunjenih štrcaljki (0,5 ml) bez igle 1 napunjena štrcaljka (0,5 ml) s iglom 10 napunjenih štrcaljki (0,5 ml) s iglom
Flucelvax Tetra induces humoral antibodies against the haemagglutinins.
Flucelvax Tetra inducira stvaranje humoralnih protutijela na hemaglutinin.
Animal data, with cell-based trivalent influenza vaccine (TIVc), have not shown effects on female fertility.
Ispitivanja na životinjama vezana uz učinke trovalentnog cjepiva protiv influence dobivenog iz stanične kulture (TIVc) ne ukazuju na učinke na plodnost u ženki.
The immunogenicity data in subjects 9 to less than 18 years of age are summarised in Table 4.
Podaci o zabilježenoj imunogenosti u ispitanika u dobi od 9 do < 18 godina sažeti su u tablici 4.
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)
GMT i stope serokonverzije (s CI 95%) u ispitanika u dobi od 9 do < 18 godina, 3 tjedna nakon cijepljenja cjepivom Flucelvax Tetra ili cjepivom TIV1c/TIV2canaliza podataka osoba koje su završili ispitivanje prema planu ispitivanja (V130_03)
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).
≥ 65 godina u usporedbi s ispitanicima u dobi 18 do < 65 godina (vidjeti tablicu u nastavku).
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.
Odgovor protutijela na sojeve virusa influence B koji su sadržani u cjepivu Flucelvax Tetra bio je bolji od odgovora protutijela nakon cijepljenja cjepivom TIVc koje sadrži soj virusa influence B iz alternativne linije uzgoja.
1 Reported as Common in the elderly population 65 years of age and older 2 Reported as Uncommon in the elderly population 65 years of age and older 3 Adverse reactions reported from post-marketing surveillance
1 Zabilježeno kao „često” u starijoj populaciji u dobi od 65 i više godina 2 Zabilježeno kao „rijetko” u starijoj populaciji u dobi od 65 i više godina
Immunogenicity of TIVc in children 9 to less than 18 years of age was evaluated as part of a randomised, double-blind, controlled study (V58P12) that was performed in the paediatric population 3 to less than 18 years of age.
Imunogenost TIVc u djece u dobi od 9 do < 18 godina procijenjena je u sklopu randomiziranog, dvostruko slijepog, kontroliranog ispitivanja (V58P12) koje se provodilo u pedijatrijskoj populaciji u dobi od 3 do < 18 godina.
Flucelvax Tetra is prepared in cell cultures, and, therefore, is egg-free.
Flucelvax Tetra se proizvodi na staničnim kulturama i stoga ne sadrži proteine jaja.
Prophylaxis of influenza in adults and children from 9 years of age.
Profilaksa influence u odraslih i djece od navršenih 9 godina nadalje.
Pack of 1 pre-filled syringe, with needle
Pakiranje s 1 napunjenom štrcaljkom s iglom.
Individual strains
Pojedinačni sojevi
There are limited data from the use of Flucelvax Tetra in pregnant women.
Podaci o primjeni cjepiva Flucelvax Tetra u trudnica su ograničeni.
Table 3: Comparative efficacy of TIVc versus placebo against culture-confirmed influenza by influenza viral subtype (V58P13)
Tablica 3: Usporedna djelotvornost cjepiva TIVc naspram placeba protiv influence potvrđene staničnom kulturom, prema virusnom podtipu (V58P13) TIVc (N=3776)
There are no reproductive and developmental toxicology studies with Flucelvax Tetra.
Nisu provedena ispitivanja reproduktivne i razvojne toksičnosti cjepiva Flucelvax Tetra.
Flucelvax Tetra suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 2019/2020 season
Flucelvax Tetra suspenzija za injekciju u napunjenoj štrcaljki cjepivo protiv influence (površinski antigen, iz staničnih kultura), inaktivirano sezona 2019/2020
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.
U ovom kliničkom ispitivanju u djece koja su primila drugu dozu cjepiva Flucelvax Tetra ili trovalentno cjepivo protiv influence dobiveno iz kulture stanica incidencija nuspojava nakon druge doze cjepiva bila je slična onoj primijećenoj nakon prve doze.
Use of Flucelvax Tetra during breast-feeding has not been studied.
Primjena cjepiva Flucelvax Tetra za vrijeme dojenja nije ispitana.
GMT (95% CI) Seroconversion Ratea 56% (48%-65%)
GMT (95% CI) Stopa serokonverzijea 56% (48%-65%)
Carton box for syringe(s) with needle: - 1 pre-filled syringe (0.5 ml) with needle - 10 pre-filled syringes (0.5 ml) with needle Carton box for syringe(s) without needle: - 10 pre-filled syringes (0.5 ml) without needle
Kartonska kutija za štrcaljku(e) bez igle: - 10 napunjenih štrcaljki (0,5 ml) bez igle Kartonska kutija za štrcaljku(e) s iglom: - 1 napunjena štrcaljka (0,5 ml) s iglom - 10 napunjenih štrcaljki (0,5 ml) s iglom
Seroconversion Rateb a For H1N1, H3N2 and B1 influenza strains TIV1c data are presented, whereas for B2 influenza strain TIV2c data are presented.
GMT (95% CI) Stopa serokonverzijeb a Za sojeve virusa influence H1N1, H3N2 i B1 prikazani su podaci za TIV1c, a za soj B2 prikazani su podaci za TIV2c.
Flucelvax Tetra is a clear to slightly opalescent suspension.
Flucelvax Tetra je bistra do blago opalescentna suspenzija.
Uncommon (≥1/1,000 to
(≥ 1/1000 do
Immunogenicity of Flucelvax Tetra in Children and Adolescents 9 to less than 18 Years of Age
Imunogenost cjepiva Flucelvax Tetra u djece i adolescenata u dobi od 9 do manje od 18 godina
Seqirus S.r.l.
Seqirus Inc.
Flucelvax Tetra provides active immunisation against four influenza virus strains (two A subtypes and two B types) contained in the vaccine.
Flucelvax Tetra omogućuje aktivnu imunizaciju protiv 4 soja virusa influence (dva podtipa
GMT (95% CI) Seroconversion Rateb
GMT (95% CI) Stopa serokonverzijeb
Bold- CHMP immunogenicity criteria met.
Masno tiskano = CHMP (Committee for Medicinal Products for Human Use) kriteriji imunogenosti su zadovoljeni.
Flucelvax Tetra is manufactured using Madin Darby Canine Kidney (MDCK) cells.
Flucelvax Tetra proizvodi se pomoću psećih bubrežnih stanica Madin Darby (engl.
Flucelvax Tetra may be given at the same time as other vaccines.
Flucelvax Tetra se smije davati istodobno s drugim cjepivima
Non-inferiority was established for all 4 influenza strains included in Flucelvax Tetra, as assessed by ratios of GMTs and the differences in the percentages of subjects achieving seroconversion at 3 weeks following vaccination.
Takva neinferiornost utvrđena je za sva 4 soja influence sadržana u cjepivu Flucelvax Tetra, kako je utvrđeno omjerom GMT-ova i razlika u postotku ispitanika kod kojih je nastupila serokonverzija 3 tjedna nakon cijepljenja.
Table 2: Noninferiority of Flucelvax Tetra relative to TIVc in adults 18 years of age and above - Per protocol analysis set (V130_01)
Tablica 2: Neinferiornost cjepiva Flucelvax Tetra u odnosu na cjepivo TIVc u odraslih u dobi od 18 i više godina - analiza podataka osoba koje su završile ispitivanje prema planu ispitivanja (V130_01)
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%.
postotak ispitanika koji su postigli titar HI ≥ 1:40 je > 70%.
The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:
Djelatne tvari su površinski antigeni virusa influence (hemaglutinin i neuraminidaza), inaktivirani,
Vaccination should be postponed in patients with acute febrile illness until the fever is resolved.
U slučaju akutne febrilne bolesti cijepljenje se mora odgoditi dok vrućica ne prođe.
There are no data available on coadministration of Flucelvax Tetra with other vaccines.
Nema dostupnih podataka o istodobnoj primjeni cjepiva Flucelvax Tetra s drugim cjepivima.
Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Flucelvax Tetra - suspenzija za injekciju u napunjenoj štrcaljki cjepivo protiv influence (površinski antigen, iz staničnih kultura), inaktivirano
Arthralgia
artralgija