FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence rates for moderate and severe pain after Optaflu vaccination are similar to those of egg-derived influenza vaccines; however a slightly increased risk for mild short-lasting injection site pain was observed with Optaflu in the subgroup of elderly vaccinees (8% compared to 6% with egg-derived influenza vaccine).
Croatian: Stope incidencija umjerene i teške boli nakon cijepljenja Optafluom slične su onima za cjepiva protiv influence dobivenih na jajima; no za Optaflu je opažen blago povećani rizik blaže boli kratkog trajanja na mjestu injiciranja u podskupini starijih cijepljenika (8% u usporedbi s 6% za cjepiva protiv influence dobivenih na jajima).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Optaflu (2015/2016 season)
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Optaflu (sezona 2015./2016.)
English: ILI was defined according to Centers for Disease Control and Prevention (CDC) case definition, i.e., a fever (oral temperature ≥ 100.0°F / 38°C) and cough or sore throat.
Croatian: ILI je definirana u skladu s definicijom Centara za kontrolu i sprječavanje bolesti, tj. povišenom temperaturom (peroralno izmjerena temperatura ≥ 100,0 °F / 38 °C) kašljem i natečenim grlom.
English: If either condition exists, do not administer the vaccine.
Croatian: Ako primijetite bilo koje od tih stanja, cjepivo nemojte primijeniti.
English: • 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.
Croatian: • Vaš liječnik ili medicinska sestra osigurat će dostupnost medicinskog liječenja i nadzora u slučaju rijetke anafilaktičke reakcije (vrlo teške alergijske reakcije sa simptomima kao što su teškoće pri disanju, omaglica, slab i ubrzan puls i kožni osip) nakon primjene.
English: The limited data from influenza vaccinations in pregnant women do not indicate that there are negative effects for the unborn child.
Croatian: Ograničeni podaci o cijepljenjima protiv influence trudnica ne ukazuju na postojanje negativnih učinaka na nerođeno dijete.
English: The immunological response may be diminished if the patient is undergoing immunosuppressant
Croatian: Imunološki odgovor može biti slabiji ako je bolesnik podvrgnut imunosupresivnom liječenju.
English: Optaflu has not been studied in the paediatric population and therefore, data on immune response are not available for this age group.
Croatian: Optaflu nije ispitivan u pedijatrijskoj populaciji pa stoga za tu dobnu skupinu nisu dostupni podaci
English: Vaccine Efficacy = (1 - Relative Risk) x 100 %; ** There were too few cases of influenza due to vaccine-matched influenza A/H3N2 or B to adequately assess vaccine efficacy.
Croatian: Djelotvornost cjepiva = (1 - povezani rizik) x 100%; ** Za odgovarajuću procjenu djelotvornosti cjepiva bilo je premalo slučajeva influence, zbog podudarnosti cjepiva s influencom A/H3N2 ili B.
English: No case of overdose has been reported for Optaflu.
Croatian: Nisu prijavljeni slučajevi predoziranja Optafluom.
English: - Local lymphadenopathy
Croatian: - Lokalna limfadenopatija
English: It is important that procedures are in place to avoid injury from faints.
Croatian: Važno je osigurati odgovarajuće mjere zaštite kako bi se izbjegle ozljede prilikom nesvjestice.
English: Keep this vaccine out of the sight and reach of children.
Croatian: Ovo cjepivo čuvajte izvan pogleda i dohvata djece.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 June 2007
Croatian: Datum prvog odobrenja: 1. lipnja 2007.
English: Influenza cases were identified by active and passive surveillance of influenza-like illness (ILI).
Croatian: Slučajevi gripe potvrđeni su aktivnim i pasivnim praćenjem bolesti slične gripi (ILI, engl. influenza-like illness).
English: It should be noted that adverse reactions may be intensified.
Croatian: Potrebno je napomenuti da se nuspojave mogu pojačati.
English: Optaflu is used to prevent flu in adults, especially in those who run an increased risk of experiencing associated complications in case they fall ill with flu.
Croatian: Optaflu se upotrebljava za sprječavanje gripe u odraslih osoba, naročito u onih koji imaju povećani rizik od povezanih komplikacija u slučaju da obole od gripe.
English: Optaflu is available in packs containing 1 or 10 pre-filled syringes and in multipacks comprising 2 cartons, each containing 10 pre-filled syringes.
Croatian: Optaflu je dostupan u pakiranjima koja sadrže 1 ili 10 napunjenih štrcaljki i u višestrukim pakiranjima od 2 kartona, od kojih svaki sadrži 10 napunjenih štrcaljki.
English: • if you are allergic to influenza vaccine or any of the other ingredients of this vaccine (listed in
Croatian: • ako ste alergični na cjepivo protiv influence ili bilo koje druge sastojke ovog cjepiva
English: In this comparative trial against an egg-derived influenza vaccine the seroprotection* rate, seroconversion or significant increase rate** and the geometric mean ratio (GMR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
Croatian: U ovom komparativnom ispitivanju u usporedbi s cjepivom protiv influence dobivenom na jajima stopa seroprotekcije*, serokonverzije ili značajno povećanje stope* i omjer geometrijske srednje vrijednosti (GMR) za anti-HA protutijelo (izmjereno pomoću HI) procijenjeni su u skladu s unaprijed
English: Immunisation should be carried out by intramuscular injection into the deltoid muscle.
Croatian: Imunizacija se provodi intramuskularnom injekcijom u deltoidni mišić.
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Croatian: Reakcija protutijela u bolesnika s endogenom ili jatrogenom imunosupresijom može biti nedostatna.
English: Optaflu may be given at the same time as other vaccines.
Croatian: Optaflu se smije davati istodobno s drugim cjepivima.
English: - Angioedema
Croatian: - Angioedem
English: Due to the kind of manufacturing Optaflu is free of When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection against the influenza virus.
Croatian: Kada osoba primi cjepivo, imunološki sustav (prirodni obrambeni sustav tijela) stvorit će vlastitu zaštitu protiv virusa influence.
English: The vaccine should be allowed to reach room temperature before use.
Croatian: Prije uporabe cjepivo treba doseći sobnu temperaturu.
English: • difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction)
Croatian: • teškoće pri disanju, omaglica, slab i ubrzan puls te kožni osip, koji su simptomi anafilaktičke reakcije (vrlo teške alergijske reakcije)
English: * produced in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in which the influenza virus is grown) ** haemagglutinin
Croatian: * umnoženo u psećim bubrežnim stanicama Madin Darby (MDCK) (to je posebna stanična kultura na kojoj se uzgaja virus influence)
English: The following adverse reactions have been observed:
Croatian: Primijećene su sljedeće nuspojave:
English: The PSUR cycle for the medicinal product should follow a twice-yearly cycle until otherwise agreed
Croatian: • Periodička izvješća o neškodljivosti (PSUR-evi) Podnošenje PSUR-a za lijek treba pratiti ciklus od dva puta godišnje do drugačije dogovorenog od
English: Optaflu is a clear to slightly opalescent suspension.
Croatian: Optaflu je bistra do blago opalescentna suspenzija.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK - Inner Carton Box for 10 pre-filled syringes with needles - Inner Carton Box for 10 pre-filled syringes without needles Inner carton box will not include “Blue Box”.
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKO PAKIRANJE - Unutarnja kartonska kutija za 10 napunjenih štrcaljki s iglama - Unutarnja kartonska kutija za 10 napunjenih štrcaljki bez igala Unutarnja kartonska kutija neće sadržavati „Plavi okvir”.
English: Healthcare professionols are asked to report any suspected adverse reactions via the national reporting sytem listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog
English: Not known (cannot be estimated from the available data):
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka):
English: Optaflu 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.
Croatian: Djelotvornost Optaflua definirana je kao sprječavanje simptomske gripe potvrđene na kulturi stanica uzrokovane virusima koji antigenski odgovaraju virusima u cjepivu u usporedbi s placebom.
English: (convulsions) (only observed with egg-derived influenza vaccines)
Croatian: (primijećeno samo kod cjepiva protiv influence dobivenih na jajima)
English: 10 pre-filled syringes without needle.
Croatian: 10 napunjenih štrcaljki bez igle.
English: • weakness beginning in the legs and progressing to the arms with numbness and tingling sensation which are symptoms of an inflammation of the nerves
Croatian: • slabost počinje u nogama i napreduje do ruku uz utrnulost i osjećaj trnaca, što su simptomi
English: 0.5 ml suspension in pre-filled syringes (type I glass), with a plunger stopper (bromobutyl rubber).
Croatian: 0,5 ml suspenzije u napunjenim štrcaljkama (staklo tipa I) s čepom klipa (brombutilna guma).
English: * Simultaneous one-sided 97.5% confidence intervals for the vaccine efficacy of each influenza vaccine relative to placebo based on the Sidak-corrected score confidence intervals for the two relative risks.
Croatian: * Istodobni jednostrani 97,5%-tni intervali pouzdanosti djelotvornosti cjepiva za svako cjepivo protiv gripe u odnosu na placebo utemeljen na intervalima pouzdanosti ispravljenim po Sidaku za dva povezana rizika.
English: Do not use this vaccine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovo cjepivo se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „Rok valjanosti”.
English: Prophylaxis of influenza for adults, especially in those who run an increased risk of associated
Croatian: Profilaksa influence u odraslih, naročito u onih koji imaju povećani rizik od povezanih komplikacija.
English: Visually inspect the contents of each Optaflu syringe for particulate matter and/or change in colour prior to administration.
Croatian: Prije primjene sadržaj svake štrcaljke Optaflua treba vizualno pregledati radi vidljivih čestica i/ili promjene boje.
English: Animal studies do not indicate reproductive toxicity (see Section 5.3 - Preclinical safety data).
Croatian: Ispitivanja na životinjama ne ukazuju na reproduktivnu toksičnost (vidjeti dio 5.3-Neklinički podaci o sigurnosti primjene).
English: Immunisation should be carried out on separate limbs.
Croatian: Imunizacija se treba provesti na suprotnim udovima.
English: Suspension for injection in pre-filled syringe.
Croatian: Suspenzija za injekciju u napunjenoj štrcaljki.
English: No differences were observed between the cell-culture and the comparator egg-derived vaccine.
Croatian: Nisu primijećene razlike između cjepiva dobivenih na kulturama stanica i uspoređivanih cjepiva dobivenih na jajima.
English: Tell your doctor if you are pregnant, think you may be pregnant or plan to become pregnant.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku.
English: Optaflu is injected into the muscle on the top of the upper arm (deltoid muscle).
Croatian: Optaflu se injicira u mišić na gornjem dijelu nadlaktice (deltoidni mišić).
English: Vaccine Efficacy* % Lower Limit of OneSided 97.5% CI
Croatian: Djelotvornost cjepiva* % Donja granica jednostranog 97,5% CI
English: Optaflu is not recommended for use in children below 18 years of age since there is no information available.
Croatian: Djeca i adolescenti: Optaflu se ne preporučuje za primjenu u djece mlađe od 18 godina jer nema dostupnih informacija.
English: None of the ingredients in the vaccine can
Croatian: Nijedan od sastojaka u cjepivu ne može uzrokovati gripu.
English: Efficacy against Culture-Confirmed Influenza
Croatian: Djelotvornost protiv gripe potvrđene na kulturi stanica
English: Note that the side effects of the vaccines may be intensified.
Croatian: Imajte na umu da bi se nuspojave cjepiva mogle pojačati.
English: Very Rare (affects less than 1 user in 10,000): • bleeding or bruising which are symptoms of a low platelet count in the blood
Croatian: Vrlo rijetko (javljaju se kod manje od 1 korisnika na 10 000): • krvarenje ili nastanak modrica, što su simptomi niskog broja trombocita u krvi
English: A/Switzerland/9715293/2013 (H3N2) - like strain
Croatian: soj sličan A/Switzerland/9715293/2013 (H3N2)
English: For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.
Croatian: U trudnih žena s medicinskim stanjima koja povećavaju rizik komplikacija zbog influence, preporučuje se primjena cjepiva, bez obzira na stadij trudnoće.
English: Overall 7253 single doses of Optaflu were administered to 6180 adults aged 18 - 60 years of age and to 1073 elderly (aged 61 years or older).
Croatian: 6180 odraslih osoba u dobi od 18 do 60 godina i 1073 starijih osoba (u dobi od 61 godinu ili starijih) primilo je ukupno 7253 jednokratnih doza Optaflua.
English: For pregnant women with medical conditions that increase their risk of complications from the flu, administration of the vaccine is recommended, irrespective of their stage of pregnancy.
Croatian: Trudnicama s medicinskim stanjima koja povećavaju rizik komplikacija od gripe, preporučuje se primjena cjepiva, bez obzira na stadij trudnoće.
English: Tell your doctor immediately if you experience any of the following side effects - you may need
Croatian: Odmah obavijestite svog liječnika ako osjetite bilo koju od sljedećih nuspojava - možda ćete trebati
English: * propagated in Madin Darby Canine Kidney (MDCK) cells
Croatian: * umnoženo u psećim bubrežnim stanicama Madin Darby (MDCK)
English: • painful disorders of the nerves, e.g. attacks of extreme pain in the face, throat or ear fits
Croatian: • bolni poremećaji živaca, npr. napadaji izrazite boli na licu, grlu ili ušima, napadaji (konvulzije)
English: In this case the vaccines should be injected into separate limbs.
Croatian: U tom se slučaju cjepiva trebaju injicirati u suprotne udove.
English: This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free'.
Croatian: Ovo cjepivo sadrži kalij, manje od 1 mmol (39 mg) po dozi, tj. sadrži zanemarive količine kalija.
English: Vaccine Efficacy*
Croatian: Djelotvornost cjepiva*
English: There is no human data on use of Optaflu during lactation.
Croatian: Ne postoje podaci o upotrebi Optaflua tijekom dojenja u ljudi.
English: Optaflu has minor influence on the ability to drive and use machines.
Croatian: Optaflu malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: - Paraesthesia
Croatian: - Parestezije
English: Male fertility has not been assessed in animals (see section 5.3).
Croatian: Plodnost u mužjaka nije procjenjivana kod životinja (vidjeti dio 5.3).
English: • flu-like symptoms such as headache, feeling of discomfort, tiredness, muscle pain.
Croatian: • simptomi nalik gripi poput glavobolje, osjećaja nelagode, umora, boli u mišićima.
English: A/California/7/2009 (H1N1)pdm09 - like strain
Croatian: soj sličan A/California/7/2009 (H1N1)pdm09 (divlji tip A/Brisbane/10/2010)
English: The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Croatian: Drugi sastojci su: natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev hidrogenfosfat dihidrat, kalijev dihidrogenfosfat i voda za injekcije.
English: Also, tell your doctor immediately if you experience any of the following side effects - you may need
Croatian: Također, odmah obavijestite svog liječnika ako osjetite bilo koju od sljedećih nuspojava - možda ćete
English: 10 pre-filled syringes with needle.
Croatian: 10 napunjenih štrcaljki s iglom.
English: Very rare (affects less than 1 user in 10,000): • skin rashes, fever, joint pain or kidney problems which are symptoms of an inflammation of the
Croatian: Vrlo rijetko (javljaju se kod manje od 1 korisnika na 10 000): • kožni osipi, vrućica, bol u zglobovima ili problemi s bubrezima koji su simptomi upale
English: Sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Croatian: Natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev hidrogenfosfat dihidrat, kalijev dihidrogenfosfat i voda za injekcije.
English: The use of Optaflu may be considered from the second trimester of pregnancy.
Croatian: Može se razmotriti primjena Optaflua od drugog tromjesečja trudnoće.
English: Animal data have not shown effects on female fertility (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na učinke na plodnost u ženki (vidjeti dio 5.3).
English: 15 micrograms HA** 15 micrograms HA** per 0.5 ml dose
Croatian: 15 mikrograma HA** 15 mikrograma HA** u dozi od 0,5 ml
English: The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains:
Croatian: Djelatne tvari su površinski antigeni virusa influence (hemaglutinin i neuraminidaza)*, inaktivirani, sljedećih sojeva:
English: Uncommon (affects 1 to 10 users in 1,000): • generalised skin reactions such as itching, bumps on the skin or non-specific rash
Croatian: Manje često (javljaju se kod 1 do 10 korisnika na 1000): • generalizirane kožne reakcije poput svrbeža, kvržica na koži ili nespecifičnog osipa
English: Data for adults were as follows (values in brackets show the 95% confidence intervals):
Croatian: U nastavku su podaci za odrasle osobe (vrijednosti u zagradama prikazuju 95%-tne intervale pouzdanosti): Tablica 4: Imunogenost u odraslih
English: - Vasculitis, possibly associated with transient renal involvement
Croatian: - Vaskulitis s mogućim povezanim prolaznim zahvaćanjem bubrega
English: - Neurological disorders, such as Guillain Barré syndrome, encephalomyelitis and neuritis
Croatian: GuillainBarréova sindroma, encefalomijelitis i neuritis
English: Optaflu suspension for injection in a pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Croatian: Optaflu suspenzija za injekciju u napunjenoj štrcaljki cjepivo protiv influence (površinski antigen, inaktivirano, pripremljeno iz staničnih kultura)
English: Optaflu is a vaccine against flu (influenza).
Croatian: Što je OPTAFLU i za što se koristi Optaflu je cjepivo protiv gripe (influence).
English: Vaccine efficacies against vaccine-matched influenza viral strains, against all influenza viral strains, and against individual influenza viral subtypes were
Croatian: Izračunate su učinkovitosti cjepiva protiv virusnih sojeva gripe koji odgovaraju cjepivu, protiv svih virusnih sojeva gripe i protiv pojedinačnih virusnih podtipova gripe (tablice 2 i 3).
English: Pack sizes of 1, 10 or multipacks containing 20 (2 packs of 10) pre-filled syringes, each with or
Croatian: Veličine pakiranja od 1, 10 ili višestruka pakiranja koja sadrže 20 (2 pakiranja od 10) napunjenih štrcaljki, svaka s iglom ili bez igle.
English: Data for elderly were as follows (values in brackets show the 95% confidence intervals):
Croatian: U nastavku su podaci za starije osobe (vrijednosti u zagradama prikazuju 95%-tne intervale pouzdanosti): Tablica 5: Imunogenost u starijih osoba
English: ** Seroconversion = negative pre-vaccination HI titer and post-vaccination HI titer ≥40; significant increase = positive pre-vaccination HI titer and at least a 4-fold increase in post-vaccination HI titer
Croatian: GMR * Seroprotekcija = HI titri ≥ 40 ** Serokonverzija = negativni HI titar prije cijepljenja i HI titar nakon cijepljenja ≥ 40; značajno povećanje = pozitivan HI titar prije cijepljenja i najmanje 4 puta povećanje HI titra nakon cijepljenja
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Prefilled syringe
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Napunjena štrcaljka
English: Very rare (affects less than 1 user in 10,000):
Croatian: Vrlo rijetko (javljaju se kod manje od 1 korisnika na 10 000):
English: • sweating, joint pain, chills, hardening or swelling at the site of the injection, bruising, fever,
Croatian: • znojenje, bol u zglobovima, zimica, otvrdnuće ili oticanje na mjestu injekcije, nastanak modrica,
English: Multipack: 20 (2 packs of 10) pre-filled syringes (0.5 ml) without needle Multipack: 20 (2 packs of 10) pre-filled syringes (0.5 ml) with needle
Croatian: Višestruko pakiranje: 20 (2 pakiranja po 10) napunjenih štrcaljki (0,5 ml) bez igle Višestruko pakiranje: 20 (2 pakiranja po 10) napunjenih štrcaljki (0,5 ml) s iglom
English: Reporting of suspected adverse reactions after authorisation of the medicinal products is important.
Croatian: Nakon dobivanja odobrenja lijeka, važno je prijavljivanje sumnji na njegove nuspojave.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Kao i kod svih injekcijskih cjepiva, odgovarajuće liječenje i medicinski nadzor trebaju uvijek biti lako dostupni u slučaju rijetkog anafilaktičkog događaja nakon primjene cjepiva.
English: Adverse reactions are listed according to the following frequency:
Croatian: Nuspojave su navedene u nastavku prema sljedećoj učestalosti:
English: Optaflu may be used during breast feeding.
Croatian: Optaflu se može koristiti tijekom dojenja.
English: INFORMATION IN BRAILLE Justification for not using Braille accepted.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
English: Optaflu should under no circumstances be administered intravascularly.
Croatian: Optaflu se ni u kojim okolnostima ne smije primijeniti intravaskularno.
English: All pack sizes are available with or without needle(s).
Croatian: Sve veličine pakiranja dostupne su s iglama
English: 15 micrograms HA** per 0.5 ml dose
Croatian: 15 mikrograma HA** u dozi od 0,5 ml
English: Optaflu should under no circumstances be injected
Croatian: Optaflu se ni u kojim okolnostima ne smije injicirati
English: Common (affects 1 to 10 users in 100):
Croatian: Često (javljaju se kod 1 do 10 korisnika na 100):
English: So far there is limited post-marketing experience with Optaflu.
Croatian: Iskustvo s Optafluom nakon stavljanja lijeka u promet dosad je ograničeno.
English: - Extensive swelling of injected limb
Croatian: Opsežno oticanje injiciranog ekstremiteta
English: Optaflu may have a minor effect on your ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima Optaflu može malo utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: A/H3N2 0.16 A/H1N1 0.16 B * Simultaneous one-sided 97.5% confidence intervals for the vaccine efficacy of each influenza vaccine relative to placebo based on the Sidak-corrected score confidence intervals for the two relative risks.
Croatian: Optaflu Placebo * Istodobni jednostrani 97,5%-tni intervali pouzdanosti učinkovitosti cjepiva za svako cjepivo protiv gripe u odnosu na placebo utemeljen na intervalima pouzdanosti ispravljenim po Sidaku za dva povezana rizika.