natgillin/translations-raw huggingface dataset:
Seroprotection is generally obtained within 3 weeks, as shown by the pivotal phase III clinical study V58P4 for the adult and elderly population. 
Serološka zaščita je navadno dosežena v 3 tednih, kot je pokazala ključna klinična študija III. faze V58P4 za populacijo odraslih in starejših bolnikov.
- Fever greater than 39.0°C 
- Telesna temperatura nad 39,0 °C
Among the overall study population enrolled, the mean age was 33 years, 55% were female, 84% were Caucasian, 7% were Black, 7% were Hispanic, and 2% were of other ethnic origin. 
Pri v študijo vključeni populaciji je bila povprečna starost 33 let, 55 % je bilo žensk, 84 % je bilo belcev, 7 % črncev, 7 % ljudi hispanskega porekla in 2 % ljudi drugega etničnega porekla.
Rare to <1/1000 
Redki do < 1/1.000
Adverse reactions are listed according to the following frequency: 
Neželni učinki so navedeni po naslednji pogostnosti:
Reporting of suspected adverse reactions after authorisation of the medicinal products is important. 
Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
Very serious side effects 
Zelo resni neželeni učinki
A multinational (US, Finland, and Poland), randomized, observer-blinded, placebo-controlled trial was performed to assess clinical efficacy and safety of Optaflu during the 2007-2008 influenza season in adults aged 18 to 49 years. 
Opravljeno je bilo mednarodno (ZDA, Finska in Poljska), randomizirano, za opazovalca slepo, s placebom nadzorovano preskušanje za oceno klinične učinkovitosti in varnosti cepiva Optaflu v sezoni gripe 2007-2008 pri odraslih osebah, starih od 18 do 49 let.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. 
Odziv protiteles pri bolnikih z endogeno ali iatrogeno imunosupresijo morda ne bo zadosten.
• if you are allergic to influenza vaccine or any of the other ingredients of this vaccine (listed in 
•če ste alergični na cepivo proti gripi ali katero koli sestavino tega cepiva (navedeno v poglavju 6);
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
If you take any medicines against cancer (chemotherapy), corticosteroid medicines (such as cortisone) or other medicines affecting the immune system, the immune response of your body may be weakened. 
Če uporabljate zdravila proti raku (kemoterapijo), kortikosteroide (recimo kortizon) ali druga zdravila, ki vplivajo na imunski system, bo morda imunski odziv vašega telesa oslabljen.
• you should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see Section 2, “Taking other medicines”). 
• morate vi povedati zdravniku, če je vaš imunski sistem okvarjen in ali prejemate zdravljenje, ki vpliva na imunski sistem, npr. zdravila proti raku (kemoterapija) ali kortikosteroidna zdravila (glejte poglavje 2, „Jemanje drugih zdravil“);
Number of Subjects with Influenza 
Število oseb z gripo
Optaflu should be used in accordance to Official guidance. 
Cepivo Optaflu je treba uporabljati v skladu z uradnimi smernicami.
The safety of Optaflu has been assessed in seven randomized, active controlled clinical trials performed as part of the development program. 
Varnost cepiva Optaflu so ocenili v sedmih randomiziranih, aktivno nadzorovanih kliničnih preskušanjih, opravljenih kot del razvojnega programa.
Date of latest renewal: 01 June 2012 
Datum prve odobritve: 1. junij 2007 Datum zadnjega podaljšanja: 1. Junij 2012
It is important that procedures are in place to avoid injury from faints. 
Pomembno je, da se postopek opravi na mestu, kjer se je možno izogniti poškodbam zaradi omedlevice.
For intramuscular use. 
Za intramuskularno uporabo.
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). 
Skupaj 7253 enkratnih odmerkov cepiva Optaflu so dali 6180 odraslim, starim od 18 do 60 let, in 1073 starejšim osebam, starim 61 let ali več.
Other medicines and Optaflu 
Druga zdravila in cepivo Optaflu
It should be noted that adverse reactions may be intensified. 
Treba je biti pozoren na to, da so lahko neželeni učinki okrepljeni.
In a repeated-dose toxicity study in rabbits there was no evidence of systemic toxicity and the vaccine was locally well tolerated. 
V študijah toksičnosti pri ponavljajočih odmerkih pri kuncih ni bilo dokazov o sistemski toksičnosti in cepivo so lokalno dobro prenašali.
The European Medicines Agency has deferred the obligation to submit the results of studies withOptaflu in one or more subsets of the paediatric population in the prevention of influenza (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s cepivom Optaflu za eno ali več podskupin pediatrične populacije za preprečevanje gripe (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The safety and efficacy of Optaflu in children and adolescents less than 18 years of age have not yet been established. 
Varnost in učinkovitost cepiva Optaflu pri otrocih in mladostnikih, starih do 18 let, še nista bili dokazani.
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. 
Kot pri vseh cepivih, ki se injicirajo, morata biti ustrezno zdravljenje in zdravstveni nadzor vedno na voljo za primer redke anafilaktične reakcije po uporabi cepiva.
All pack sizes are available with or without needle(s). 
Vse velikosti pakiranj so na voljo z iglami ali brez njih.
In the elderly frequencies were similar, except for myalgia, headache and injection site pain which were classified as ‘common'. 
Pri starejših je bila pogostnost podobna, z izjemo mialgije, glavobola in bolečine na mestu injiciranja, ki so bili razvrščeni kot ‘pogosti'.
This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. 
Spremlja jo lahko več nevroloških znakov, kot so prehodne motnje vida, parestezija in tonično-klonični gibi udov med okrevanjem.
Seroconversion/Significant increase rate 
Stopnja serološke zaščite Stopnja serološke konverzije/ pomembnega povečanja
Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07BB02 
Farmakoterapevtska skupina: Cepiva proti gripi, Oznaka ATC: J07BB02
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you. 
Pred začetkom uporabe natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
(convulsions) (only observed with egg-derived influenza vaccines) 
(konvulzije) (opazili so jih samo pri cepivih proti gripi, pridobljenih iz jajc).
A total of 11,404 subjects were enrolled to receive Optaflu (N=3828), Agrippal (N=3676) or placebo (N=3900) in a 1:1:1 ratio. 
Vključenih je bilo skupno 11.404 oseb, ki so prejele cepivo Optaflu (N=3828), cepivo Agrippal (N=3676) ali placebo (N=3900) v razmerju 1:1:1.
No effects on the breastfed newborn /infant are anticipated. 
Učinki na dojene novorojence/otroke se ne pričakujejo.
Data for adults were as follows (values in brackets show the 95% confidence intervals): 
Podatki pri odraslih so bili naslednji (vrednosti v oklepajih so 95-odstotni intervali zaupanja):
Immunisation should be carried out on separate limbs. 
Imunizacijo je treba opraviti na ločenih okončinah.
In this case the vaccines should be injected into separate limbs. 
V takšnem primeru je treba cepiva injicirati v ločene okončine.
Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1. 
Po cepljenju proti gripi so lahko rezultati seroloških preizkusov z metodo ELISA za odkrivanje protiteles proti virusu-1 humane imunske pomanjkljivosti (HIV-1), virusu hepatitisa C in zlasti proti virusu HTLV-1 lažno pozitivni.
What you need to know before you receive OPTAFLU 
Kaj morate vedeti, preden boste prejeli cepivo OPTAFLU
** Thrombocytopenia (some very rare cases were severe with platelet counts less than 5000 per mm3) 
** Trombocitopenija (zelo redki primeri so bili hudi s številom trombocitov manj kot 5.000 na mm
The limited data from influenza vaccinations in pregnant women do not indicate that there are negative effects for the unborn child. 
Omejeni podatki iz cepljenj proti gripi pri nosečnicah ne kažejo na negativne vplive za nerojenega otroka.
These transitory false-positive results may be due to IgM production in response to the vaccine. 
Ti prehodno lažno pozitivni rezultati so lahko posledica nastajanja protiteles IgM na cepivo.
A single syringe contains 0.5 ml of suspension for injection. 
Posamezna brizga vsebuje 0,5 ml suspenzije za injiciranje.
The safety of Optaflu in pregnancy and breast-feeding has not been assessed in clinical trials. 
Varnosti cepiva Optaflu v nosečnosti in pri dojenju niso ocenili v kliničnih preskušanjih.
Detailed information on this medicine is available on the European Medicines Agency web site: 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
Like all medicines, this vaccine can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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). 
Stopnja pogostnosti zmerne in hude bolečine po cepljenju s cepivom Optaflu je podobna stopnji pri cepivih, pridobljenih iz jajc; vendar so pri cepivu Optaflu opazili rahlo povečano tveganje za pojav blage kratkotrajne bolečine na mestu injiciranja v podskupini starejših oseb, ki so jih cepili (8 % v primerjavi s 6 % pri cepivu, pridobljenem iz jajc).
The vaccine should be allowed to reach room temperature before use. 
Cepivo se mora pred uporabo ogreti na sobno temperaturo.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Optaflu (2015/2016 season) 
IME ZDRAVILA IN POT(I) UPORABE Optaflu (sezona 2015/2016)
Not known (cannot be estimated from the available data) Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
neznana (ni mogoče oceniti iz razpoložljivih podatkov) V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
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. 
V tem primerjalnem preskušanju s cepivom, pridobljenim iz jajc, so bili stopnja serološke zaščite*, stopnja serološke konverzije ali pomembnega povečanja** in razmerje geometrične srednje vrednosti (GMR - Geometric Mean Ratio) za protitelesa proti HA (izmerjeno z inhibicijo hemaglutinina) ocenjeni glede na predhodno določene kriterije.
• 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. 
• bosta zdravnik ali medicinska sestra zagotovila, da bosta na voljo ustrezno zdravljenje in zdravstveni nadzor v primeru redke anafilaktične reakcije (zelo hude alergijske reakcije s simptomi, kot so težave pri dihanju, vrtoglavica, šibek in hiter srčni utrip ter kožni izpuščaj) po uporabi.
% Lower Limit of One-Sided 97.5% CI 
% Spodnja meja enostranskega 97,5-% IZ
Healthcare professionols are asked to report any suspected adverse reactions via the national reporting sytem listed in Appendix V. 
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
What Optaflu is and what it is used for What you need to know before you receive Optaflu 
Kaj je cepivo Optaflu in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli cepivo Optaflu
Influenza cases were identified by active and passive surveillance of influenza-like illness (ILI). 
Primeri gripe so bili odkriti z aktivnim in pasivnim spremljanjem gripi podobnih bolezni (ILI - influenza-like illness).
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. 
ILI so opredelili v skladu z opredelitvijo primera Centra za nadzor in preprečevanje bolezni (Centers for Disease Control and Prevention (CDC)), tj. zvišana telesna temperatura (oralna temperatura ≥38 °C) in kašelj ali boleče žrelo.
Optaflu may be given at the same time as other vaccines. 
Cepivo Optaflu se lahko daje sočasno z drugimi cepivi.
• if you have an acute illness associated with fever. 
• če imate akutno bolezen, ki jo spremlja povišana telesna temperatura.
Across all three influenza strains, for the egg-derived vaccine seroprotection rates ranged between 85% and 98%, seroconversion or significant increase rates ranged between 62% and 73% and GMRs ranged between 5.52- and 8.76-fold over baseline HI titers. 
Pri vseh treh sevih gripe je bila stopnja serološke zaščite pri cepivih, pridobljenih iz jajc, med 85 in 98 %, stopnja serološke konverzije ali pomembnega povečanja je bila med 62 in 73 %, razmerje geometrične srednje vrednosti pa je bilo od 5,52- do 8,76-kratno v primerjavi z izhodiščnimi titri HI.
Outer carton box will include “Blue Box”. 
Zunanja kartonska škatla vključuje podatke za tako imenovano »modro okence«.
This reaction may occur with Optaflu as with all vaccines that are injected. 
Do te reakcije lahko pride pri uporabi cepiva Optaflu tako kot pri vseh cepivih, ki se injicirajo;
- Neurological disorders, such as Guillain Barré syndrome, encephalomyelitis and neuritis 
- Nevrološke motnje, kot so GuillainBarréjev sindrom, encefalomielit is in nevritis
Immunisation should be carried out by intramuscular injection into the deltoid muscle. 
Imunizacijo je treba opraviti z intramuskularnim injiciranjem v deltoidno mišico.
Prophylaxis of influenza for adults, especially in those who run an increased risk of associated 
Profilaksa gripe pri odraslih, zlasti pri tistih, pri katerih obstaja večje tveganje za zaplete, povezane
Optaflu has not been studied in the paediatric population and therefore, data on immune response are not available for this age group. 
Cepiva Optaflu pri pediatrični populaciji niso raziskovali, zato podatki o imunskem odzivu pri tej
A/Switzerland/9715293/2013 (H3N2) - like strain 
Sevu A/Switzerland/9715293/2013 (H3N2) podoben sev
Neuralgia, convulsion, febrile convulsion. 
Nevralgija, konvulzija, febrilna konvulzija.
The following side effects have been observed during clinical trials and post-marketing surveillance: 
Naslednje neželene učinke so opazili med kliničnimi preskušanji in v obdobju po začetku trženja:
No differences were observed between the cell-culture and the comparator egg-derived vaccine. 
Razlik med celično kulturo in primerjalnim cepivom, pridobljenim iz jajc, niso opazili.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET
- Vasculitis, possibly associated with transient renal involvement 
- Vaskulitis, ki je lahko povezan s prehodno prizadetostjo ledvic
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. 
Učinkovitost cepiva = (1 - relativno tveganje) x 100 %; ** Primerov gripe, ki bi se ujemali s cepilnima sevoma virusa gripe A/H3N2 in B, je bilo premalo za
OTHER SPECIAL WARNING(S), IF NECESSARY Do not inject intravascularly. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Ne injicirajte intravaskularno.
Tell your doctor if you are pregnant, think you may be pregnant or plan to become pregnant. 
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom.
Tell the doctor requesting the test that you have recently received Optaflu. 
Zdravniku, ki je teste naročil, povejte, da ste se pred kratkim cepili s cepivom Optaflu.
Table 2: Vaccine Efficacy against Culture-Confirmed Influenza Attack Rate (%) 
Preglednica 2: Učinkovitost cepiva proti laboratorijsko potrjeni gripi z gripo Pojavnost (%)
** 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. 
** Serološka konverzija = negativni titer HI pred cepljenjem in titer po cepljenju ≥ 40; pomembno povečanje = pozitiven titer HI pred cepljenjem in vsaj 4-kratno povečanje titra HI po cepljenju.
Efficacy against Culture-Confirmed Influenza 
Učinkovitost proti laboratorijsko potrjeni gripi
Vaccine Efficacy* % Lower Limit of OneSided 97.5% CI 
Učinkovitost cepiva* % Spodnja meja enostranskega 97,5-% IZ
A/California/7/2009 (H1N1)pdm09 - like strain 
Sevu A/California/7/2009 (H1N1)pdm09 podoben sev
Optaflu may have a minor effect on your ability to drive and use machines. 
Cepivo Optaflu ima lahko majhen vpliv na vašo sposobnost vožnje in upravljanja strojev.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect - you may need urgent medical attention or hospitalisation: 
Takoj povejte zdravniku ali pojdite v ambulanto za nujne primere v najbližjo bolnišnico, če opazite naslednje neželene učinke; morda boste potrebovali nujno medicinsko pomoč ali se boste morali
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. 
Ko je oseba cepljena, bo imunski sistem (naravni obrambni sistem telesa) začel proizvajati lastno zaščito proti virusu gripe.
Ask you pharmacist how to throw away medicines you no longer use. 
O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
Therefore, Optaflu is not recommended for use in children and adolescents less than 18 years of age (see section 5.1). 
Uporaba cepiva Optaflu pri otrocih in mladostnikih, starih do 18 let, zato ni priporočljiva (glejte poglavje 5.1).
Optaflu is available in packs containing 1 or 10 pre-filled syringes and in multipacks comprising 2 cartons, each containing 10 pre-filled syringes. 
Cepivo Optaflu je na voljo v pakiranjih z 1 ali 10 napolnjenimi injekcijskimi brizgami in v večkratnih pakiranjih z 2 škatlama, od katerih vsaka vsebuje po 10 napolnjenih injekcijskih brizg.
• difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction) 
• težave pri dihanju, vrtoglavica, šibek in hiter srčni utrip ter kožni izpuščaj, ki so simptomi anafilaktičnega reakcije (zelo hude alergijske reakcije).
The use of this vaccine may be considered from the second trimester of pregnancy. 
O možnosti uporabe cepiva se lahko odloča od drugega trimesečja nosečnosti naprej.
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 cepiva se izteče na zadnji dan navedenega meseca.
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'.
• painful disorders of the nerves, e.g. attacks of extreme pain in the face, throat or ear fits 
• boleče motnje živcev, npr. napadi hude bolečine v obrazu, grlu ali ušesu; epileptični napadi
Suspension for injection in pre-filled syringe. 
Suspenzija za injiciranje v napolnjeni injekcijski brizgi.
Immunisation shall be postponed in patients with febrile illness or acute infection. 
Pri bolnikih s febrilno boleznijo ali akutno okužbo je treba imunizacijo preložiti.
Optaflu contains sodium chloride and potassium chloride This vaccine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'. 
Cepivo Optaflu vsebuje natrijev klorid in kalijev klorid To cepivo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
Your doctor will decide if you should receive Optaflu. 
Vaš zdravnik se bo odločil, ali boste cepljeni s cepivom Optaflu.
This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
The use of Optaflu may be considered from the second trimester of pregnancy. 
Možnost uporabe cepiva Optaflu se lahko pretehta od drugega trimesečja nosečnosti naprej.
Justification for not using Braille accepted. 
Sprejeta je utemeljitev, da Braillova pisava ni potrebna
* 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. 
* Sočasni enostranski 97,5-odstotni intervali zaupanja za učinkovitost cepljenja s cepivi proti gripi glede na placebo, ki temeljijo na Šidakovih intervalih zaupanja s korekcijo točk za obe vrednosti relativnega tveganja.
Optaflu is not recommended for use in children below 18 years of age since there is no information available. 
Otroci in mladostniki: Uporabe cepiva Optaflu se ne priporoča za otroke, stare manj kot 18 let, saj podatki niso na voljo.
Male fertility has not been assessed in animals (see section 5.3). 
Plodnost samcev na živalih ni bila ocenjena (glejte poglavje 5.3).
• flu-like symptoms such as headache, feeling of discomfort, tiredness, muscle pain. 
• simptomi, podobni gripi, kot so glavobol, občutek nelagodja, utrujenost, bolečine v mišicah.
Optaflu may be used during breast feeding. 
Cepivo Optaflu se lahko uporablja med dojenjem.
* propagated in Madin Darby Canine Kidney (MDCK) cells 
* razmnoženi v celicah pasjih ledvic Madin Darby (MDCK)
Animal studies do not indicate reproductive toxicity (see Section 5.3 - Preclinical safety data). 
Študije na živalih ne kažejo vplivov na sposobnost razmnoževanja (glejte poglavje 5.3 - Predklinični podatki o varnosti).
In general data from influenza vaccinations in pregnant women do not indicate adverse foetal and maternal outcomes attributable to the vaccine. 
Podatki iz cepljenj proti gripi pri nosečnicah na splošno ne kažejo na neželene učinke na plod ali mater, ki bi jih lahko pripisali cepivu.
Very Rare (affects less than 1 user in 10,000): • bleeding or bruising which are symptoms of a low platelet count in the blood 
Zelo redki (pojavijo se pri manj kot 1 od 10.000 cepljenih): • krvavitve ali modrice, ki so simptomi majhnega števila trombocitov v krvi.