natgillin/translations-raw huggingface dataset:
These reactions usually disappear within 1-2 days without treatment.
Te reakcije navadno izginejo v 1 do 2 dneh brez zdravljenja.
Adults and elderly: 0.5 ml at an elected date.
Odrasli in starejši: 0,5 ml na izbrani datum.
This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product.
To pomeni, da iz znanstvenih razlogov ni bilo mogoče pridobiti vseh podatkov o zdravilu.
The following age groups will be used: < 2 years, 2-8 years, > 9 years.
Uporabljajo se naslednje starostne skupine: < 2 leti, 2-8 let, ≥ 9 let.
- “Cumulatively” means since the use of the vaccine; events not reported during the period of interest should not be presented in the tables.
- „Kumulativno“ pomeni od začetka uporabe cepiva; dogodki, o katerih v obdobju interesa niso poročali, se v teh tabelah ne predstavijo.
The following principles should be followed when compiling the data:
Pri zbiranju podatkov se upoštevajo naslednja načela:
The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
Znaki pandemične gripe so podobni kot pri običajni gripi, vendar so lahko resnejši.
Those which have not yet been entered should be reported in the following S-PSUR.
Dogodki, ki še niso bili vneseni, bodo vključeni v naslednje poročilo S-PSUR.
1 Based on the assumption that product name will not be provided in a significant proportion of cases.
1 Na podlagi predpostavke, da v znatnem številu primerov ime zdravila ne bo znano.
- Italy Store in a refrigerator.
- Italija Shranjujte v hladilniku.
narrow SMQ “Demyelination” (as GBS is also included in this SMQ, there will be an overlap in the number of cases for these two categories).
zoženo SMQ „Demielinacija“ (ker je GBS tudi vključen v to SMQ, se bodo številni primeri za ti dve kategoriji prekrivali).
A short summary should be provided in which validated signals and areas of concern are highlighted, taking into account information arising from the prospective cohort study described in 4.5.
Priskrbeti je treba kratek povzetek, ki potrdi signale in v katerem so poudarjena področja, ki povzročajo skrbi, ob upoštevanju informacij, ki izhajajo iz prospektivne kohortne študije, opisane v poglavju 4.5.
Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades.
Pandemična gripa je vrsta gripe, ki se pojavlja v presledkih, ki trajajo od manj kot 10 let do več desetletij.
• Frequency of submission:
• Pogostnost predložitve:
It spreads rapidly around the world.
Pandemična gripa se zelo hitro širi po svetu.
In the event of multiple signals, signal work-up may be prioritised and appropriate timelines for submission of a full signal evaluation report should be provided.
V primeru več signalov se lahko da prednost obdelavi signalov in določijo ustrezni roki za predložitev poročila o ocenitvi vseh signalov.
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Pred uporabo cepiva natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
It is important that procedures are in place to avoid injury from faints.
Pomembno je, da so uvedeni postopki, s katerimi se preprečijo telesne poškodbe zaradi omedlevice.
During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan
Med pandemijo bo predlagatelj opravil prospektivno kohortno študijo, kot je opredeljeno v načrtu farmakovigilance.
If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Če stanje pandemije dovoljuje, je treba imunizacijo pri bolnikih s hudo febrilno boleznijo ali akutno okužbo preložiti.
These transitory false-positive results may be due to IgM production in response to the vaccine.
Ti prehodni lažno pozitivni rezultati so lahko posledica nastajanja IgM kot odziv na cepivo.
Results are shown by SRH.
Rezultati so prikazani s pomočjo SRH.
It is best to see how Foclivia affects you before you try these activities.
Najbolje je, da preskusite, kako zdravilo Foclivia vpliva na vas, preden začnete s temi dejavnostmi.
- All non-medically confirmed events are those that have been entered into the database by the data-lock point.
- Vsi nemedicinsko potrjeni dogodki so tisti, ki so bili vneseni v bazo podatkov do konca zaključenega obdobja zbiranja podatkov.
See section 6.5 for the number of doses per vial.
Glejte poglavje 6.5 za število odmerkov v viali.
Immunogenicity was assessed in a subset (n=197) of the study population.
Imunogenost so ocenili v podskupini (n = 197) populacije študije.
The vaccine contains an ‘adjuvant' (a compound containing squalene) to stimulate a better response.
Cepivo vsebuje „adjuvans“ (spojino, ki vsebuje skvalen) za spodbujanje boljšega odziva.
The report should include the following Tables of aggregate data (using the pre-defined templates attached in Annex 2).
Poročilo mora vsebovati naslednje tabele združenih podatkov (izdelane z dogovorjenimi predlogami, priloženimi v Prilogi 2).
Foclivia should be used in accordance with Official Guidance.
Zdravilo Foclivia je treba uporabljati v skladu z uradnimi smernicami.
It should be noted that the adverse reactions may be intensified.
Treba je biti pozoren na to, da so lahko neželeni učinki okrepljeni.
Very rare (<1/10,000):
Zelo redki (< 1/10.000):
In such cases, the side effects may be more intense).
V takšnih primerih so učinki lahko močnejši.
Data are available that suggest that multidose vials could be used up to a maximum of 72 hours after first withdrawal, although such pro-longed storage periods should not be the preferred option.
Na voljo so podatki, ki nakazujejo, da se večodmerne viale lahko uporabljajo največ 72 ur po odvzemu prvega odmerka, čeprav tako dolgo obdobje shranjevanja ni zaželeno.
The safety and efficacy of Foclivia in subjects under 18 years of age have not yet been established.
Varnost in učinkovitost zdravila Foclivia pri preiskovancih, starih do 18 let, še nista bili dokazani.
- All tables will be based on generic and not product-specific data1.
- Vse tabele bodo zasnovane na generičnih podatkih, ne pa na podatkih za specifična zdravila1.
Tell your doctor if you have any known allergies.
Zdravnika obvestite, če imate katero koli dokazano alergijo.
Do not throw away any medicines via wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali gospodinjske odpadke.
Currently available data in subjects aged 6 months to 18 years of age are described in section 5.1 but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki pri preiskovancih, starih od 6 mesecev do 18 let, so opisani v poglavju 5.1, vendar priporočil o odmerjanju ni mogoče dati.
- The clock should start from the first Monday after shipment of the first batch of vaccine.
- Čas se začne meriti prvi ponedeljek po dostavi prve serije cepiva.
Foclivia contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose.
Zdravilo Foclivia vsebuje manj kot 1 mmol natrija (23 mg) in manj kot 1 mmol kalija (39 mg) na odmerek.
Fertility No fertility data are available.
Plodnost Podatki glede plodnosti niso na voljo.
- A line listing of fatal cases will be provided in an Annex.
- V prilogi bodo našteti vsi fatalni primeri.
NA*** N=69
n/s*** n = 69
NA***
n/s***
Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italy.
Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italija.
Pandemic preparedness vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Cepiva za pripravljenost na pandemijo vsebujejo antigene gripe, ki so razlikujejo od antigenov trenutno prisotnih virusov gripe.
None of the ingredients in the vaccine can cause flu.
Nobena sestavina cepiva ne povzroča gripe.
During a pandemic situation, the resources must be concentrated on a timely and effective monitoring of the safety profile of the influenza vaccines used during the pandemic.
V času pandemične situacije je treba vire osredotočiti na pravočasno in učinkovito nadziranje profila varnosti cepiva proti gripi, ki se uporablja v času pandemije.
A protective response may not be elicited in all vaccine recipients (see section 5.1).
Zaščitni odziv morda ne bo sprožen pri vseh prejemnikih cepiva (glejte poglavje 5.1).
Foclivia has been authorised under “Exceptional Circumstances”.
Zdravilo Foclivia je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
• Post-marketing surveillance
• Nadzor v obdobju trženja
Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italy
Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italija
Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or use machines.
Nekateri učinki, navedeni v poglavju 4.8 „Neželeni učinki“, lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
Adjuvant MF59C.1 containing: Squalene
Adjuvans MF59C.1 vsebuje: skvalen
NA*** N=36
n/s*** n = 36
They are isolated from the surface of influenza virus particles, which are grown in fertilised hen's eggs from healthy chicken flocks and inactivated with formaldehyde.
Izolirani sta iz delcev plašča virusa gripe, ki jih gojijo v oplojenih kokošjih jajcih iz jat zdravih piščancev in ki so inaktivirani s formaldehidom.
As with all vaccines, Foclivia may not fully protect all persons who are vaccinated.
Kot vsa cepiva tudi zdravilo Foclivia morda popolnoma ne zaščiti vseh cepljenih oseb.
4.7 Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanja s stroj
Excipients: Thiomersal
Pomožne snovi: tiomersal
This is a multidose container.
To je vsebnik z več odmerki.
MN results, similar to SRH results demonstrated strong immune response after completion of priming vaccination series in a population of elderly subjects.
Podobno kot rezultati SRH kažejo tudi rezultati MN močan imunski odgovor po končani seriji primarnega cepljenja v populaciji starejših oseb.
Moreover, a 6-monthly cycle may be too long to allow assessment of the safety of a vaccine for which high levels of exposure are expected within a short period of time.
Lahko se zgodi, da bo 6-mesečni cikel predolg za varnostni nadzor cepiva proti pandemični okužbi, pri katerem se pričakuje visoka raven izpostavljenosti v kratkem časovnem obdobju.
Product-specific data can be evaluated during signal work-up.
Podatki za specifična zdravila se lahko ocenijo med prvo obdelavo signalov.
This vaccine complies with the WHO recommendations and EU decision for the pandemic.
Cepivo je skladno s priporočili SZO in odločbo EU za pandemijo.
Some side effects listed in Section 4.
Nekateri učinki, navedeni v poglavju 4.8.
Focetria (H1N1v)
Zdravilo Focetria (H1N1v)
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 redkih anafilaktičnih dogodkov po uporabi cepiva.
However, if co-administration with another vaccine is indicated, immunisation should be carried out on separate limbs.
Vendar, če je sočasno cepljenje z drugim cepivom indicirano, je treba imunizacijo opraviti na ločenih okončinah.
No data are available in children aged less than 6 months.
Podatki pri otrocih, starih do 6 mesecev, niso na voljo.
Depending on and after implementation of vaccine when first pandemic will take place.
Odvisno od uporabe cepiva in po uporabi cepiva v primeru prve pandemije.
Immune response to vaccination assessed by MN assay is in line with results obtained with SRH.
Imunski odziv na cepljenje, ocenjen s testom MN, je v skladu z rezultati, pridobljenimi s testom SRH.
The percentages of subjects reporting local reactions were higher in the older age groups, mainly due to the higher reports for pain.
Odstotek oseb, ki so navedle lokalne neželene učinke, je bil večji v starejših skupinah, zlasti zaradi pogostejših navedb o bolečini.
However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
Vendar je v primeru pandemije lahko cepljenje s tem cepivom primerno, če je takoj na voljo oprema za oživljanje za nujne primere.
Since a second dose is recommended, it should be noted that there are no safety, immunogenicity or efficacy data to support interchangeability of Foclivia with other H5N1 monovalent vaccines.
Ker je priporočljivo cepljenje z drugim odmerkom, je treba opozoriti, da ni podatkov o varnosti, imunogenosti ali učinkovitosti, ki podpirajo zamenljivost zdravila Foclivia z drugimi monovalentnimi cepivi H5N1.
What Foclivia is and what it is used for
Kaj je zdravilo Foclivia in za kaj ga uporabljamo
Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli zdravilo, tudi če ste ga dobili brez recepta.
During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Med pandemijo bo predlagatelj zbral podatke o klinični varnosti in učinkovitosti pandemičnega cepiva in te podatke predložil v oceno komisiji CHMP.
When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering the period since the data lock point of the last routine PSUR will be submitted within a time frame to be agreed with the Rapporteur.
Ko se CHMP strinja, da poročila S-PSUR več niso potrebna, se v časovnem obdobju, dogovorjenem s poročevalcem, predloži celotno poročilo PSUR, ki pokriva obdobje od zaključenega obdobja zbiranja podatkov zadnjega običajnega poročila PSUR.
These viral proteins are prepared from the strain of influenza virus that complies with the World Health Organisation recommendations and EU decision in an officially declared Pandemic situation.
Virusne beljakovine so pripravljene iz seva virusa gripe, ki je skladen s priporočili Svetovne zdravstvene organizacije in odločbo EU pri uradno razglašeni pandemiji.
The adjuvant includes also polysorbate 80 and sorbitan trioleate in a citrate buffer (sodium citrate, citric acid).
Adjuvans vsebuje tudi polisorbat 80 in sorbitantrioleat v citratnem pufru (natrijev citrat, citronska kislina).
This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
To lahko spremlja več nevroloških znakov, kot so prehodna motnja vida, parestezija in tonično-klonični gibi udov med okrevanjem.
Only spontaneously reported data should be included in the PSUR.
V poročilo PSUR se vključijo samo podatki, o katerih se poroča spontano.
Therefore, 6-monthly or annual PSURs falling within the pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by a summary of vaccine distribution.
Zato se 6-mesečna ali letna redna dopolnjena poročila o varnosti zdravila znotraj obdobja pandemije nadomestijo z mesečnimi poenostavljenimi rednimi dopolnjenimi poročili o varnosti zdravila (S-PSUR), ki se jim predloži povzetek porazdelitve cepiva.
injection into the deltoid muscle
injiciranje v deltoidno mišico
Warning: Do not inject intravascularly or subcutaneously.
Opozorilo: Ne injicirajte intravaskularno ali subkutano.
Instructions for administration of the vaccine:
Navodila za dajanje cepiva:
It has to be used in adults (from 18 to 60 years old) and elderly (over 60 years) to prevent flu caused by the H5N1 type of the virus.
Uporablja se pri odraslih (starih od 18 do 60 let) in starejših bolnikih (starejših od 60 let) za preprečevanje gripe, ki jo povzroča virus tipa H5N1.
- if you feel feverish, - if you have any illness or infection, - if you are having immunosuppressive therapy, e.g. corticosteroid treatment or chemotherapy for cancer, or if you have any condition which makes you prone to infections (immunodeficiency conditions).
- če imate zvišano telesno temperaturo, - če imate katero koli bolezen ali okužbo, - če prejemate imunosupresivno zdravljenje, npr. kortikosteroide ali kemoterapijo proti raku, ali če imate kakršno koli bolezen, zaradi katere ste dovzetni za okužbe (pomanjkanje imunosti).
Other medicines and Foclivia
Druga zdravila in zdravilo FOCLIVIA
Children and adolescents aged 6 months to 17 years:
Otroci in mladostniki, stari od 6 mesecev do 17 let:
* propagated in fertilised hens' eggs from healthy chicken flocks ** expressed in microgram haemagglutinin.
* namnoženi v oplojenih kokošjih jajcih iz jat zdravih piščancev ** izraženo v mikrogramih hemaglutinina.
Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI and possible adverse events related to adjuvants.
Zunaj obdobja pandemije se ohrani običajno časovno obdobje in format predložitve PSUR, in sicer s posebnim pregledom neželenih učinkov posebnega interesa in možnih neželenih učinkov, povezanih z adjuvansi.
narrow SMQ “Non-infectious encephalitis”
zoženo SMQ „Ne-infekcijski encefalitis“
The majority of febrile convulsions occurred in paediatric subjects.
Večina febrilnih konvulzij se je pojavila pri otrocih.
Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07BB02
Farmakoterapevtska skupina: cepiva proti gripi, oznaka ATC: J07BB02
Your doctor or nurse administers the vaccine in accordance with official recommendations.
Cepivo vam bosta dala zdravnik ali medicinska sestra v skladu z uradnimi priporočili.
One dose (0.5 ml) of the vaccine contains at least 7.5 micrograms of haemagglutinin from the following recommended influenza virus strain:
En odmerek (0,5 ml) cepiva vsebuje vsaj 7,5 mikrogramov hemaglutinina iz naslednjih priporočenih sevov virusa gripe:
This should include data from ongoing studies, or actual use if applicable, of the pandemic preparedness strains and any safety data relevant to the adjuvant system.
Vključeni morajo biti podatki potekajočih študij ali, če je ustrezno, dejanske uporabe sevov za pripravljenost na pandemijo in podatkov o varnosti, pomembnih za adjuvantni sistem.
EU/1/09/577/001 1 prefilled syringe with needle EU/1/09/577/002 10 prefilled syringes with needle EU/1/09/577/005 1 prefilled syringe without needle EU/1/09/577/006 10 prefilled syringes without needle
EU/1/09/577/001 1 napolnjena injekcijska brizga z iglo EU/1/09/577/002 10 napolnjenih injekcijskih brizg z iglo EU/1/09/577/005 1 napolnjena injekcijska brizga brez igle EU/1/09/577/006 10 napolnjenih injekcijskih brizg brez igle
What Foclivia is and what it is used for What you need to know before you receive Foclivia How Foclivia is given
Kaj je zdravilo Foclivia in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Foclivia Kako uporabljati zdravilo Foclivia
Your doctor needs to assess the benefits and potential risks of giving you the vaccine.
Zdravnik mora oceniti koristi in možno tveganje zaradi cepiva.
A dose (0.5 ml) of the vaccine will be injected into the upper arm (deltoid muscle).
Odmerek (0,5 ml) cepiva vam bodo injicirali v zgornji del roke (deltoidno mišico).
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Znaki alergijske reakcije lahko vključujejo srbečo kožo, zasoplost, otekanje obraza ali jezika.
Two doses of 7.5 micrograms were administered three weeks apart and a third dose 12 months following the first dose.
V presledku treh tednov so dali dva odmerka po 7,5 mikrograma in tretji odmerek 12 mesecev po prvem odmerku.
Serum samples were tested against the original H5N3 and also a number of H5N1 isolates.
Vzorce seruma so preizkusili proti izvirnemu izolatu H5N3 in proti številnim izolatom H5N1.
There is limited experience for the booster dose in the elderly population.
Izkušnje za obnovitveni odmerek pri starejši populaciji so omejene.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this vaccine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali medicinsko sestro, preden se cepite s tem cepivom.
Reactogenicity after a third dose, administered 12 months after the second dose, was higher than after both first and second dose.
Reaktogenost po tretjem odmerku, ki je bil dan 12 mesecev po drugem odmerku, je bila večja kot po prvem in drugem odmerku.
Foclivia is a milky-white liquid.
Zdravilo Foclivia je mlečno bela tekočina.
Adverse reactions from clinical trials with the pandemic preparedness vaccine Foclivia are listed below.
Neželeni učinki v kliničnih preskušanjih s cepivom Foclivia za pripravljenost na pandemijo so navedeni spodaj.
Health care providers need to assess the benefits and potential risks of administering Foclivia vaccine to pregnant women, taking into consideration official recommendations.
Zdravnik mora presoditi koristi in možno tveganje uporabe zdravila Foclivia pri nosečnicah, pri čemer mora upoštevati uradna priporočila.
Rare (>1/10,000, <1/1,000): Thrombocytopenia (some very rare cases were severe with platelet counts less than 5.000 per mm3).
Redki (> 1/10.000, < 1/1.000): Trombocitopenija (nekaj zelo redkih primerov s številom trombocitov pod 5.000 na mm3).
Foclivia should not be given at the same time as other vaccines (if another vaccine is required at the same time, then the injection should be carried out on a different limb.
Zdravilo Foclivia se ne sme dajati sočasno z drugimi cepivi (če je sočasno cepljenje z drugim cepivom nujno, ga je treba injicirati v drugo okončino.
This section describes the clinical experience with the H5N1 pandemic preparedness vaccines following a two-dose administration of 7.5 microgram.
V tem poglavju so opisane klinične izkušnje s cepivi proti H5N1 za pripravljenost na pandemijo po uporabi dveh odmerkov cepiva 7,5 mikrogramov.
Adjuvant: MF59C.1 oil in water emulsion containing squalene, as the oil phase, stabilised with polysorbate 80 and sorbitan trioleate in a citrate buffer (sodium citrate, citric acid).
Adjuvans: MF59C.1 emulzija olja v vodi, ki vsebuje skvalen kot oljno fazo in je stabilizirana s polisorbatom 80 in sorbitantrioleatom v citratnem pufru (natrijev citrat, citronska kislina).
Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems) and exudative Stevens-Johnson syndrome (erythema multiforme).
Vaskulitis (vnetje krvnih žil, ki lahko povzroči kožne izpuščaje, bolečine v sklepih in težave z ledvicami) in eksudativni Stevens-Johnsonov sindrom (multiformni eritem).
Seroprotection rate (95% CI) Day 43 Seroconversion factor (95% CI) Day 43 to Day 1 Seroconversion rate (95% CI) Day 43 * In the absence of CHMP immunogenicity criteria for children, the CHMP immunogenicity criteria used to evaluate seasonal flu vaccines in adults were applied to the serological data obtained after vaccination of children.
43. dan Faktor serokonverzije (95-odstotni IZ) 43. dan do 1. dan Stopnja serokonverzije (95-odstotni IZ) 43. dan * V odsotnosti kriterijev CHMP za imunogenost za otroke so bili za oceno seroloških podatkov po cepljenju otrok uporabljeni kriteriji CHMP za imunogenost za oceno sezonskih cepiv proti gripi za odrasle.
Adults and elderly (above 18 years old).
Odrasli in starejši (starejši od 18 let):
Although Foclivia in multidose vials contains a preservative that inhibits microbial growth, minimisation of the risk of contamination of the multidose vial during withdrawal of each dose is the responsibility of the user.
Foclivia v večodmernih vialah vsebuje konzervans, ki zavira rast mikrobov, je uporabnik odgovoren za zmanjšanje tveganja kontaminacije večodmerne viale med odvzemom vsakega odmerka.
First dose
Prvi odmerek
When a person is given the vaccine, the body's natural defence system (immune system) produces its own protection (antibodies) against the disease.
Po cepljenju naravni obrambni sistem telesa (imunski sistem) napravi zaščito (protitelesa) proti bolezni.