natgillin/translations-raw huggingface dataset:
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 or have recently received any other vaccine.
Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta, ali če ste bili cepljeni z drugim cepivom.
Compared to the antibody levels obtained at day 43 after completion of primary vaccination schedules, antibody levels at day 202 were reduced by 1/5 to 1/2 from their prior levels.
V primerjavi z ravnmi protiteles, pridobljenimi 43. dan po zaključku primarnega režima cepljenja, so bile ravni protiteles 202. dan zmanjšane za 1/5 do 1/2 glede na predhodne ravni.
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.
“Possible side effects” may affect the ability to drive or use machines.
„Možni neželeni učinki“, lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
Animals received one or two doses of vaccine containing 3.75 or 7.5 micrograms of antigen, followed by challenge with a lethal dose of A/Vietnam/1203/04 virus.
Živali so prejele enega ali dva odmerka cepiva, ki je vsebovalo 3,75 ali 7,5 mikrograma antigena, čemur je sledila provokacija z letalnim odmerkom virusa A/Vietnam/1203/04.
These side effects usually disappear within 1-2 days without treatment.
Ti neželeni učinki običajno izzvenijo v 1-2 dneh brez zdravljenja.
Do not use AFLUNOV after the expiry date which is stated on the carton and the label.
Cepiva AFLUNOV ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki.
* propagated in fertilised hens' eggs from healthy chicken flocks ** expressed in microgram haemagglutinin.
* namnožen v oplojenih kokošjih jajcih iz jat zdravih piščancev ** izraženo v mikrogramih hemaglutinina
The following solicited adverse reactions were additionally collected in these two studies and reported with the following frequencies across subjects who received AFLUNOV irrespective of age or health status: diarrhoea (up to 11.9%), loss of appetite (up to 10.9%) and vomiting (up to 1.7%).
V okviru sistematičnega poročanja so v teh dveh študijah zabeležili tudi naslednje neželene učinke, ki so imeli naslednje pogostnosti pri vseh skupinah oseb, udeleženih v študijah, ki so prejele cepivo AFLUNOV, ne glede na starost ali zdravstveno stanje: driska (do 11,9 %), izguba apetita (do 10,9 %) in bruhanje (do 1,7 %).
EU/1/10/658/001 1 prefilled syringe EU/1/10/658/002 10 prefilled syringes
EU/1/10/658/001 1 napolnjena injekcijska brizga EU/1/10/658/002 10 napolnjenih injekcijskih brizg
Warning: Do not inject intravascularly or intradermally.
Opozorilo: ne injicirajte intravaskularno ali intradermalno.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Znaki alergijske reakcije so lahko med drugim kožni osip, zasoplost in oteklost obraza ali jezika.
Since AFLUNOV is expected not to be used in an emergency situation, its administration during pregnancy might be deferred as a precautionary approach.
Ker se ne pričakuje, da bi se cepivo AFLUNOV uporabljalo v nujnih situacijah, se lahko uporaba med nosečnostjo preloži kot previdnostni ukrep.
Packs of 1 or 10 pre-filled syringes.
Pakiranja po 1 ali 10 napolnjenih injekcijskih brizg.
Healthy N=62
Zdravi N = 62
Post-marketing spontaneously reported adverse events and an interventional study do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy.
Na podlagi neželenih učinkov, o katerih so spontano poročali po pridobitvi dovoljenja za promet, in intervencijske študije se ne predvideva neposrednih ali posrednih škodljivih učinkov izpostavljenosti cepivu Focetria na nosečnost.
Healthy N=57
Zdravi N = 57
What AFLUNOV is and what it is used for
Kaj je cepivo AFLUNOV in za kaj ga uporabljamo
Anti-HA antibody (SRH)
Protitelo proti HA (SRH)
Study V87_25
Študija V87_25
Study V87_26
Študija V87_26
Persistence of antibodies after primary vaccination in this population was assessed by hemagglutination inhibition (HI), SRH, and MN assays.
Obstojnost protiteles po primarnem cepljenju v tej populaciji je bila ocenjena s testi zaviranja hemaglutinacije (HI), SRH in MN.
The incidence of adverse reactions has been evaluated in seven clinical trials in healthy subjects involving over 4300 adults and elderly receiving AFLUNOV (at least 7.5 µg HA, adjuvanted).
Pogostnost neželenih učinkov so ocenili v sedmih kliničnih preskušanjih pri zdravih osebah, ki so zajela čez 4.300 odraslih in starejših oseb, ki so prejele cepivo AFLUNOV (vsaj 7,5 µg HA, z adjuvansom).
*actual age range of population enrolled
*dejanski razpon starosti vključene populacije
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Omogoča namreč stalno spremljanje razmerja med koristmi in tveganji cepiva.
• Anaphylaxis (severe allergic reactions).
• anafilaksa (hude alergijske reakcije).
87% of animals challenged with virus heterologous to the vaccine strain after 2 doses of vaccine were protected, and a single dose of heterologous vaccine protected 56% of the animals.
87 % živali, provociranih z virusom, heterolognim na cepilni sev, je bilo zaščitenih po 2 odmerkih cepiva, en odmerek heterolognega cepiva pa je zaščitil 56 % živali.
However, in immunocompromised subjects 18 through 60 years of age, slightly higher rates of nausea (13.0%) were reported.
Vendar pa so pri osebah z oslabljenim imunskim sistemom, starih od 18 let do vključno 60 let, poročali o rahlo višjih stopnjah navzee (13,0 %).
• in the presence of immune deficiencies AFLUNOV may be administered but a protective immune response may not be elicited.
• v prisotnosti imunske pomanjkljivosti se cepivo AFLUNOV lahko daje, vendar ni nujno, da bo dosežen zaščitni imunski odziv.
Across studies V87_25 and V87_26, the safety of AFLUNOV in healthy adult and elderly subjects was consistent with existing safety data from previous clinical trials.
V študijah V87_25 in V87_26 je bila varnost cepiva AFLUNOV pri zdravih odraslih in starejših osebah skladna z obstoječimi podatki o varnosti iz prejšnjih kliničnih preskušanj.
Excipient with known effect: The vaccine contains 1.899 milligrams of sodium and 0.081 milligrams of potassium per 0.5 ml dose.
Pomožne snovi z znanim učinkom: Cepivo vsebuje 1,899 miligrama natrija in 0,081 miligrama kalija na odmerek 0,5 ml.
Do not throw any medicines via wastewater or household waste.
Cepiva ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
• Erythema multiforme (type of allergic skin reaction that occurs in response to medications,
• Multiformni eritem (vrsta alergijske kožne reakcije, ki se pojavi v odziv na zdravila, okužbe ali bolezen).
In a similar study, intranasal challenge was delayed until approximately 4 months after the second dose of vaccine was administered.
V podobni študiji so z intranazalno provokacijo počakali približno 4 mesece po drugem odmerku cepiva.
Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare
Zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
In this study 100% of animals were protected against homologous challenge, and 81% of animals were protected against heterologous challenge.
V tej študiji je bilo pred homologno provokacijo zaščitenih 100 % živali in pred heterologno provokacijo 81 % živali.
As with all vaccines, AFLUNOV may not fully protect all persons who are vaccinated.
Kot druga cepiva morda tudi cepivo AFLUNOV ne bo popolnoma zaščitilo vseh cepljenih oseb.
These studies provided limited immunogenicity data in subjects with some underlying medical (in particular, renal impairment and peripheral cardiovascular disease) and immunosuppressive conditions (in particular, transplant recipients and patients under cancer treatment).
Ti študiji sta podali omejene podatke o imunogenosti pri osebah z nekaterimi osnovnimi bolezenskimi stanji (zlasti okvaro ledvic in periferno srčno-žilno boleznijo) in zmanjšanim imunskim odzivom (zlasti pri prejemnikih presadkov in bolnikih, ki se zdravijo zaradi raka).
In the absence of compatibility trials, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti cepiva ne smemo mešati z drugimi zdravili.
Lung damage was reduced in vaccinated groups.
Poškodbe pljuč v cepljenih skupinah so bile manjše.
• Allergic reactions possibly with shortness of breath, wheezing, swelling of the throat, or leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock.
• Alergijske reakcije, ki so lahko vključevale kratko sapo, sopenje, oteklost grla ali alergijske reakcije, ki povzročijo nevarno znižanje krvnega tlaka, ki lahko, če stanje ni zdravljeno,
However, in a pandemic situation, it may be appropriate for you to be vaccinated with AFLUNOV provided that appropriate medical treatment is immediately available in case of an allergic reaction.
Vendar bo v primeru pandemije cepljenje s cepivom AFLUNOV za vas morda priporočljivo, če bo takoj na voljo ustrezna medicinska oprema za primer alergijske reakcije.
AFLUNOV may not fully protect everyone who is vaccinated, especially elderly subjects and those with weakened immune systems, such as HIV patients, or those with underlying long term medical problems, such as diabetes, lung disease or heart problems.
Cepivo AFLUNOV vseh cepljenih oseb morda ne zaščiti povsem, še posebej starejših oseb in tistih z oslabljenim imunskim sistemom, kot so bolniki, okuženi z virusom HIV, ali bolniki z dolgotrajnimi osnovnimi bolezenskimi stanji, kot so diabetes, pljučna bolezen ali težave s srcem.
Paediatric population The safety and efficacy of AFLUNOV in subjects under 18 years of age have not yet been established.
Varnost in učinkovitost cepiva AFLUNOV pri preiskovancih, starih do 18 let, še nista bili dokazani.
What AFLUNOV is and what it is used for What you need to know before you receive AFLUNOV How AFLUNOV is given
Kaj je cepivo AFLUNOV in za kaj ga uporabljamo Kaj morate vedeti, preden boste cepljeni s cepivom AFLUNOV Kako se daje cepivo AFLUNOV
• Angioedema (abnormal swelling of the skin, usually around the eyes, lips, tongue, hands or feet, due to an allergic reaction).
• angioedemom (nenormalno oteklostjo kože zaradi alergijske reakcije, ponavadi na območju oči, ustnic, jezika, dlani ali stopal).
All animals receiving 2 doses of AFLUNOV were protected, and 94% of animals receiving a single dose of AFLUNOV were protected.
Zaščitene so bile vse živali, ki so prejele 2 odmerka cepiva AFLUNOV, in 94 % živali, ki so prejele en odmerek cepiva AFLUNOV.
In both studies, subjects with underlying medical and immunosuppressive conditions reported higher frequencies of diarrhoea, loss of appetite and vomiting compared to healthy subjects (irrespective of age).
V obeh študijah so osebe z osnovnimi bolezenskimi stanji ali zmanjšanim imunskim odzivom poročale o večji pogostnosti driske, izgube apetita in bruhanja v primerjavi z zdravimi osebami (ne glede na starost).
Tell the doctor requesting these tests that you have recently been given AFLUNOV.
Povejte zdravniku, ki je pregled naročil, da ste bili pred kratkim cepljeni s cepivom AFLUNOV.
Across all ages, low percentages of subjects reported fever.
V vseh starostnih skupinah je bil odstotek poročane povišane telesne temperature nizek.
When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease.
Imunski sistem (naravni obrambni sistem telesa) osebe, ki dobi cepivo, začne izločati lastno zaščito (protitelesa) proti bolezni.
Gently shake before use.
Pred uporabo nežno pretresite.
Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.
Alergijske reakcije, anafilaksa vključno z dispnejo, bronhospazem, edem grla, ki v redkih primerih povzročijo šok
AFLUNOV contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per 0.5 ml dose, i.e. essentially sodium- and potassium-free.
Cepivo AFLUNOV vsebuje manj kot 1 mmol natrija (23 mg) in manj kot 1 mmol kalija (39 mg) na odmerek 0,5 ml, kar pomeni, da je v bistvu brez natrija in kalija.
Data in children and adolescents suggest a slight decrease in side effects after the second dose of the vaccine, with no increase in rates of fever.
Podatki za otroke in mladostnike kažejo rahlo znižanje neželenih učinkov po drugem odmerku cepiva brez pogostejšega pojavljanja zvišane telesne temperature.
PSUR submission when AFLUNOV is used during an influenza pandemic:
Predložitev PSUR za cepivo AFLUNOV med pandemijo gripe:
Adults and elderly (18 years of age and above):
Odrasli in starejši bolniki (stari 18 let ali več):
• swelling, pain and redness at the injection site extending to more than 10 cm and lasting more than one week (Injection site cellulitis-like reaction)
• Otekanje, bolečina in rdečina na mestu injiciranja na območju več kot 10 cm, ki traja več kot en teden (celulitisu podobna reakcija na mestu injiciranja).
Up to 50% (n=33) of the elderly subjects aged 62 to 88 years immunised with AFLUNOV in trial V87P1 were seroprotected at six months.
Do 50 % (N = 33) starejših oseb, starih od 62 let do 88 let ter imuniziranih s cepivom AFLUNOV v preskušanju V87P1, je bilo v šestem mesecu serozaščitenih.
The vaccine contains per 0.5 ml 9.75 mg squalene, 1.175 mg polysorbate 80, 1.175 mg sorbitan trioleate.
Cepivo vsebuje na 0,5 ml 9,75 mg skvalena, 1,175 mg polisorbata 80 in 1,175 mg sorbitantrioleata.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
• Swollen lymph nodes, palpitations (irregular or forceful heart beat), tachycardia (faster than normal heart beat), weakness, pain in the extremities, cough and asthenia (unusual weakness).
• Otekle bezgavke, palpitacije (neredno ali močno bitje srca), tahikardija (hitrejše bitje srca kot normalno), slabotnost, bolečina okončin, kašelj in astenija (neobičajna oslabelost)
Children (3-<9 years)
Otroci (3-< 9 let)
In toddlers, erythema and tenderness were the most commonly reported solicited local reactions; irritability and unusual crying were the most commonly reported solicited systemic reactions.
Pri malčkih so bile najpogostejše pričakovane lokalne reakcije eritem in napetost; razdražljivost in neobičajen jok sta bili najpogosteje poročani pričakovani sistemski reakciji.
One dose of 0.5 ml contains: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in fertilised hens' eggs from healthy chicken flocks, of strain:
En odmerek (0,5 ml) vsebuje: površinske antigene (hemaglutinin in nevraminidaza) virusa influence, namnoženega v oplojenih kokošjih jajcih iz jat zdravih piščancev, seva:
In both trials, immunogenicity of AFLUNOV was shown by HI, SRH and MN assays following both the first and second dose.
V obeh preskušanjih so dokazali imunogenost cepiva AFLUNOV s testi HI, SRH in MN po prvem in po drugem odmerku.
V87P11 Adults (18-60 years) N=186
V87P11 odrasli (18-60 let) N = 186
Results are shown by SRH.
Rezultati so prikazani s testom SRH.
Fever ≥ 38°C (≥ 40°C)
vsi lokalni sistemski zvišana telesna temperatura ≥ 38 °C (≥ 40 °C)
One dose of 0.5 ml at an elected date.
En odmerek 0,5 ml se uporabi na izbrani dan.
In the event of an officially declared influenza pandemic due to A/H5N1 virus, persons previously vaccinated with one or two doses of AFLUNOV that contained haemagglutinin (HA) antigen derived from a different clade of the same influenza subtype as the influenza pandemic strain may receive a single dose of AFLUNOV instead of two doses that are required in previously unvaccinated individuals (see section 5.1).
V primeru uradne objave pandemije gripe zaradi virusa A/H5N1 lahko osebe, predhodno cepljene z enim ali dvema odmerkoma cepiva AFLUNOV, ki vsebuje hemaglutininski (HA) antigen, izpeljan iz drugačne gruče enakega podtipa gripe kot pandemski sev gripe, prejmejo en odmerek cepiva AFLUNOV namesto dveh, ki sta potrebna za predhodno necepljene osebe (glejte poglavje 5.1).
After shaking, the normal appearance of AFLUNOV is a milky-white suspension.
Normalen videz cepiva AFLUNOV po pretresanju je mlečno bela suspenzija.
In trial V87_25 and V87_26, 96 and 67 subjects, respectively, were over the age of 70 years.
V preskušanju V87_25 oziroma V87_26 je bilo 96 oseb oziroma 67 oseb starejših od 70 let.
Heterologous immune response against A/Indonesia/5/2005 (clade 2.1) was detectable in study V87P11 after the second vaccination, indicating cross-reactivity of the clade 2.2.1 vaccine against clade 2.1 strains.
Heterologni imunski odziv na A/Indonesia/5/2005 (gruča 2.1) so zaznali v študiji V87P11 po drugem cepljenju, kar kaže na križno reaktivnost cepiva gruče 2.2.1 proti sevom gruče 2.1.
• Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems)
• Vaskulitis (vnetje krvnih žil, ki lahko povzroči kožne izpuščaje, bolečine v sklepih in težave z ledvicami).
However, it is estimated that during the 2009 H1N1 pandemic more than 90,000 women were vaccinated during pregnancy with Focetria (an H1N1 pandemic vaccine similar to AFLUNOV) which contains the same amount of adjuvant MF59C.1 as AFLUNOV.
Vendar se ocenjuje, da je bilo med pandemijo H1N1 leta 2009 med nosečnostjo cepljenih več kot 90.000 žensk s cepivom Focetria (pandemsko cepivo H1N1, podobno cepivu AFLUNOV), ki vsebuje enako količino adjuvansa MF59C.1 kot cepivo AFLUNOV.
In these trials, lower levels of antibodies and reduced seroprotection rates against homologous H5N1 A/turkey/Turkey/1/2005 were also measured in healthy elderly subjects, as compared to healthy adults, though previous studies showed induction of sufficiently immunogenic responses against H5N1 strains (see above for information on elderly).
V teh preskušanjih so tudi pri zdravih starejših osebah izmerili nižje ravni protiteles in znižane ravni serozaščite proti homolognemu sevu H5N1 A/turkey/Turkey/1/2005 v primerjavi z zdravimi odraslimi osebami, čeprav so prejšnje študije pokazale vzpostavitev zadostnih imunogenih odzivov proti sevom H5N1 (glejte zgoraj za informacije o starejših osebah).
A study in rabbits did not indicate reproductive or developmental toxicity of AFLUNOV (see section 5.3).
Študija pri kuncih ni pokazala vpliva cepiva AFLUNOV na sposobnost razmnoževanja ali razvoja (glejte poglavje 5.3).
administered 12 months following the first dose, was higher than after both first and second doses.
Reaktogenost po tretjem odmerku, danem 12 mesecev po prvem odmerku, je bila višja kot po obeh, prvem in drugem odmerku.
Subjects with underlying medical or immunosuppressive conditions:
Osebe z osnovnimi bolezenskimi stanji ali zmanjšanim imunskim odzivom:
However, in a pandemic situation caused by the strain included in this vaccine, it may be appropriate to give this vaccine to individuals with a history of anaphylaxis as defined above, provided that facilities for resuscitation are immediately available in case of need.
Vendar pa je lahko v pandemski situaciji, ki jo povzroči sev, vključen v to cepivo, posameznika z anafilakso v anamnezi, kot je opredeljeno zgoraj, ustrezno cepiti, če je v takšnem primeru takoj na voljo oprema za reševanje.
Limited data were obtained from women who became pregnant during the course of clinical trials with AFLUNOV or similar pandemic H1N1v vaccines adjuvanted with MF59C.1.
Pridobili so omejene podatke pri ženskah, ki so zanosile v teku kliničnih preskušanj s cepivom AFLUNOV ali podobnimi pandemskimi cepivi H1N1v z adjuvansom MF59C.1.
Data on safety of a booster dose of AFLUNOV are limited to three trials (V87P1, V87P2 and V87P1E1) that included 116 adults (18-60 years) and 56 elderly subjects (>61 years).
Podatki o varnosti obnovitvenega odmerka cepiva AFLUNOV so omejeni na tri preskušanja (V87P1, V87P2 in V87P1E1), v katera je bilo vključenih 116 odraslih (18-60 let) in 56 starejših oseb (≥ 61 let).
The vaccine should under no circumstances be administered intravascularly or intradermally.
V nobenem primeru se ne sme cepiva dati intravaskularno ali intradermalno.
Undesirable effects in patients with underlying long term medical problems such as diabetes, lung disease or heart problems and weakened immune systems (immunocompromised) such as HIV patients
Neželeni učinki pri bolnikih z dolgotrajnimi osnovnimi bolezenskimi stanji, kot so diabetes, pljučna bolezen ali težave s srcem, in oslabljenim imunskim sistemom, kot pri bolnikih, okuženih z virusom HIV (imunsko oslabljenih bolnikih)
The adverse reaction rates reported after any vaccination doses (i.e. 1st, 2nd or booster) were similar and are listed according to the following MedDRA frequency convention and system organ class:
Seznam neželenih učinkov Stopnje neželenih učinkov, o katerih so poročali po katerem koli odmerku cepljenja (tj. 1., 2. ali obnovitvenem), so bile podobne in so naštete glede na naslednjo opredelitev pogostnosti in organskih sistemov po MedDRA:
• Neuritis (inflammation of nerves)
• nevritis (vnetje živcev).
(≥1/10,000 to
(≥ 1/1.000 do
0.5 ml in pre-filled syringe (type I glass) with plunger-stopper (bromo-butyl rubber).
0,5 ml v napolnjeni injekcijski brizgi (steklo tipa I) z zamaškom na batu (bromobutilna guma).
• Low blood platelet count which can result in bleeding or bruising.
• Zmanjšano število trombocitov v krvi, kar lahko povzroči krvavitve ali modrice.
• Headache, dizziness, drowsiness, fainting.
• Glavobol, omotičnost, zaspanost, omedlevica
Neurological disorders such as
• Nevrološke motnje, kot so:
The other ingredients are: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.
Druge sestavine zdravila so: natrijev klorid; kalijev klorid; kalijev dihidrogen fosfat; dinatrijev fosfat dihidrat; magnezijev klorid heksahidrat; kalcijev klorid dihidrat, natrijev citrat, citronska kislina in voda za injekcije.
Efficacy against challenge with virus homologous and heterologous to vaccine strains was evaluated in the ferret model.
Učinkovitost proti provokaciji z virusom, homolognim in heterolognim na cepilne seve, so ocenili pri belem dihurju.
In children and adolescents, pain was the most frequently reported solicited local reaction, and fatigue and headache were the most commonly reported solicited systemic reactions.
Pri otrocih in mladostnikih je bila najpogosteje poročana lokalna reakcija bolečina, najpogosteje poročani pričakovani sistemski reakciji pa sta bili utrujenost in glavobol.
If they persist, CONSULT YOUR DOCTOR.
Če ne izzvenijo, SE POSVETUJTE
SP= seroprotection SC= seroconversion
SK = serokonverzija
A third (booster) dose of AFLUNOV was administered 6 months onwards after the primary vaccination.
Tretji (obnovitveni) odmerek cepiva AFLUNOV je bil dan po 6 ali več mesecih po primarnem cepljenju.
This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/turkey/Turkey/1/2005 (H5N1)-like strain (see sections 4.4 and 5.1).
Ta indikacija temelji na podatkih o imunogenosti za zdrave osebe, stare 18 let ali več, po cepljenju z dvema odmerkoma cepiva, ki vsebuje sevu A/turkey/Turkey/1/2005 (H5N1) podoben sev (glejte poglavji 4.4 in 5.1).
A slight increase in reactions in adults was reported when a booster dose was administered 18 months after the initial dosing series.
Poročali so o rahlem povečanju reakcij pri odraslih, ki so obnovitveni odmerek prejeli 18 mesecev po prvi seriji odmerkov.