natgillin/translations-raw huggingface dataset:
There are no data concerning human fertility.
Plodnost Nema podataka koji se odnose na plodnost u ljudi.
The suspension is a milky-white liquid.
Suspenzija je mliječnobijela tekućina.
Package leaflet: information for the user AFLUNOV suspension for injection in pre-filled syringe
Uputa o lijeku: Informacije za korisnika AFLUNOV suspenzija za injekciju u napunjenoj štrcaljki
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 dostupni podaci u ispitanika u dobi od 6 mjeseci do 18 godina opisani su u dijelu 5.1
Protection against influenza There is no immune correlate of protection established for influenza A (H5N1).
Nije utvrđen imunološki korelat zaštite za influencu A (H5N1).
Adults (18-60 years)
Odrasli (18-60 godina)
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% životinja izloženih postvakcinacijskoj provokaciji virusom koji je heterologan soju cjepiva bilo je zaštićeno nakon 2 doze cjepiva, dok je samo jedna doza heterolognog cjepiva zaštitila 56% životinja.
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.
U usporedbi s razinama protutijela dobivenim 43. dan nakon dovršetka rasporeda prvog cijepljenja, razine protutijela 202. dana smanjile su se za 1/5 do 1/2 u odnosu na prethodne vrijednosti.
AFLUNOV is a vaccine for use in adults from 18 onwards, intended to be given in the context of outbreaks of zoonotic influenza viruses (coming from birds) with pandemic potential to prevent flu caused by H5N1 viruses similar to the vaccine strain reported in section 6.
AFLUNOV je cjepivo za primjenu u odraslih osoba u dobi od 18 godina nadalje, namijenjeno za primjenu u kontekstu izbijanja gripe izazvane zoonoznim virusom (virusom koji dolazi od ptica) s pandemijskim potencijalom, a radi sprječavanja gripe uzrokovane H5N1 virusima sličnima soju u cjepivu kako je navedeno u dijelu 6.
Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare
Vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i
Ferrets received one or two doses of vaccine (A/Vietnam/1194/2004).
Afrički tvorovi primili su jednu ili dvije doze cjepiva (A/Vietnam/1194/2004).
The vaccine contains per 0.5 ml 9.75 mg squalene, 1.175 mg polysorbate 80, 1.175 mg sorbitan trioleate.
Cjepivo po dozi od 0,5 ml sadrži 9,75 mg skvalena, 1,175 mg polisorbata 80, 1,175 mg sorbitan trioleata.
Immunocompromised N=139
Imunološki kompromitirani N=139
a actual age range of population enrolled
a trenutni raspon godina populacije uključene u ispitivanje
• Severe stabbing or throbbing pain along one or more nerves
• Neurološki poremećaji poput • Jake probadajuće ili pulsirajuće boli duž jednog ili više živaca
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:
Stope nuspojava prijavljenih nakon bilo koje doze primljenog cjepiva (tj. 1., 2. ili boostera) bile su slične i navedene su prema MedDRA definicijama učestalosti nuspojava i klasifikaciji organskih sustava:
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).
U slučaju službeno proglašene pandemije influence prouzročene virusom A/H5N1 osobe prethodno cijepljene s jednom ili dvije doze cjepiva AFLUNOV koje je sadržavalo antigen hemaglutinin (HA) dobiven iz različite klade (genetske podskupine) istog podtipa influence kao pandemijski soj influence mogu primiti samo jednu dozu cjepiva AFLUNOV umjesto dviju doza koje su potrebne u prethodno necijepljenih pojedinaca (vidjeti dio 5.1).
(≥1/10,000 to <1/1,000); Very rare (<1/10,000).
<1/1000) i vrlo rijetko (<1/10 000).
Name and address of the manufacturers of the biological active substance Seqirus Vaccines Ltd
Naziv i adresa proizvođača biološke djelatne tvari Seqirus Vaccines Ltd
Based on data obtained from trials V87P1, V87P11 and V87_13, persistence of antibodies after primary vaccination in elderly subjects as assessed by HI, SRH, and MN tests reduced from 1/2 to 1/5th of their post-vaccination level at day 202 as compared to day 43 after completion of primary schedules.
Na temelju podataka prikupljenih u ispitivanjima V87P1, V87P11 i V87_13, postojanost protutijela nakon prvog cijepljenja u starijih ispitanika procijenjena na temelju HI, SRH i MN analiza smanjila se s 1/2 na 1/5 njihove postvakcinalne razine 202. dana u usporedbi s 43. danom nakon dovršetka rasporeda primarnog cijepljenja.
The incidence of AFLUNOV (A/Vietnam/1194/2004) adverse reactions has been evaluated in one clinical trial (V87P6) in children (6 months to 17 years old).
Incidencija nuspojava cjepiva AFLUNOV (A/Vietnam/1194/2004) procijenjena je u jednom kliničkom ispitivanju (V87P6) u djece (u dobi od 6 mjeseci do 17 godina).
A third (booster) dose of AFLUNOV was administered 6 months onwards after the primary vaccination.
Treća (booster) doza cjepiva AFLUNOV primijenjena je 6 mjeseci nadalje nakon prvog cijepljenja.
Injection 1
Injekcija 1
AFLUNOV contains sodium and potassium.
AFLUNOV sadrži natrij i kalij
Data obtained in adults showed that AFLUNOV can be given at the same time as non-adjuvanted seasonal influenza vaccines.
Podaci dobiveni u odraslih osoba pokazali su da se AFLUNOV može primijeniti istodobno s neadjuvantiranim cjepivima protiv sezonske gripe.
*actual age range of population enrolled
*trenutni raspon dobi populacije uključene u ispitivanje
If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Ako se razmatra istodobna primjena s drugim cjepivom, imunizaciju treba provesti na suprotnim udovima.
Two doses of AFLUNOV were administered three weeks apart and a third dose 12 months following the first dose.
Dvije doze cjepiva AFLUNOV primijenjene su u razmaku od tri tjedna, a treća doza 12 mjeseci nakon prve doze.
1.175 milligrams per 0.5 ml sorbitan trioleate
1,175 miligrama na 0,5 ml sorbitan trioleat
1.175 milligrams per 0.5 ml
1,175 miligrama na 0,5 ml
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).
Podaci o sigurnosti booster doze cjepiva AFLUNOV ograničeni su na tri ispitivanja (V87P1, V87P2 i V87P1E1) koja su uključivala 116 odraslih osoba (18-60 godina) i 56 starijih osoba (≥61 godine).
The following additional adverse events were reported from post-marketing surveillance with seasonal non-adjuvanted trivalent vaccines in all age groups and a seasonal trivalent MF59-adjuvanted subunit influenza vaccine approved for use in elderly subjects 65 years of age and older:
Sljedeći dodatni štetni događaji prijavljeni su tijekom praćenja nakon stavljanja u promet sezonskih neadjuvantiranih trovalentnih cjepiva u svim dobnim skupinama i sezonskog trovalentnog MF59 adjuvantiranog podjediničnog cjepiva protiv influence, a koje je odobreno za primjenu u starijih osoba u dobi od 65 godina naviše:
The side effects listed below have occurred in the days or weeks after vaccination with another vaccine called Focetria H1N1v similar to AFLUNOV.
Niže navedene nuspojave pojavile su se u danima ili tjednima nakon cijepljenja drugim cjepivom naziva Focetria H1N1v, a koje je slično cjepivu AFLUNOV.
administered 12 months following the first dose, was higher than after both first and second doses.
Reaktogenost nakon treće doze, primijenjene 12 mjeseci nakon prve doze, bila je viša nego nakon prve i druge doze.
How AFLUNOV is given
Kako se AFLUNOV daje
• extensive swelling of injected limb lasting more than one week.
• Prekomjerno oteknuće ekstremiteta u koji je ubrizgano cjepivo, a koje traje duže od jednog tjedna
Warning: Do not inject intravascularly or intradermally.
Upozorenje: ne injicirati u žilu ili u kožu.
In this study 100% of animals were protected against homologous challenge, and 81% of animals were protected against heterologous challenge.
U tom je ispitivanju 100% životinja bilo zaštićeno od postvakcinacijske provokacije homolognim virusom, a 81% životinja bilo je zaštićeno od postvakcinacijske provokacije heterolognim virusom.
9.75 milligrams per 0.5 ml polysorbate 80
9,75 miligrama na 0,5 ml polisorbat 80
There are no data regarding the use of AFLUNOV during breast-feeding.
Nema podataka o uporabi cjepiva AFLUNOV tijekom dojenja.
Nervous system disorders Neurological disorders, such as encephalomyelitis, and Guillain Barré syndrome.
Poremećaji živčanog sustava Neurološki poremećaji kao što su encefalomijelitis i Guillain Barréov sindrom
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).
U tim ispitivanjima su u zdravih starijih ispitanika također izmjerene niže razine protutijela i smanjene stope seroprotekcije protiv homolognog virusa podtipa H5N1 A/turkey/Turkey/1/2005 u usporedbi sa zdravim odraslima, iako su prethodna ispitivanja pokazala induciranje dovoljnog imunosnog odgovora protiv sojeva H5N1 (vidjeti gore za podatke za starije osobe).
Injection 2
Injekcija 2
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA ŠTRCALJKU
Name and address of the manufacturer responsible for batch release Seqirus Vaccines Ltd
Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Seqirus Vaccines Ltd
AFLUNOV has been evaluated in healthy adults (18-60 years of age) and healthy elderly (over 60 years of age) following a 1, 22 day primary vaccination schedule, and booster vaccination (see sections 4.8 and 5.1).
AFLUNOV je procijenjen u zdravih odraslih osoba (u dobi od 18 do 60 godina) i zdravih starijih osoba (u dobi od 60 godina naviše) uz raspored primarnog cijepljenja po principu na dan 1, pa 22 dana te booster cijepljenje (vidjeti dijelove 4.8 i 5.1).
One dose of 0.5 ml will be given.
Daje se jedna doza od 0,5 ml.
Some degree of cross-reactive immunity has been observed against H5N1 viruses of clades different to that of the vaccine strain.
Izvjesni stupanj križnog reaktivnog imunonosnog odgovora primjećen je protiv virusa H5N1koji pripadaju kladama različitim od klada soja iz cjepiva.
• Low blood platelet count which can result in bleeding or bruising.
• Smanjen broj trombocita koji može dovesti do krvarenja ili nastanka modrica.
MN results yielded a GMR against A/turkey/Turkey/2005 ranging from 1.59 to 2.95.
Rezultati MN analize pokazali su da je srednja geometrijska vrijednost (GMR) protiv virusa A/turkey/Turkey/2005 u rasponu od 1,59 do 2,95.
Adolescents(9-<18 years)
Adolescenti (9-<18 godina)
Medical Conditions N=140
Medicinsko stanje N=140
• Convulsions
• Konvulzije
A single vaccination with AFLUNOV (A/Vietnam/1194/2004) induced high and rapid serological response in subjects primed 6-8 years previously with two doses of a different surrogate H5N vaccine, having same formulation as AFLUNOV but using the strain H5N3.
Samo jedno cijepljenje cjepivom AFLUNOV (A/Vietnam/1194/2004) izazvalo je snažan i brz serološki odgovor u ispitanika koji su primarno cijepljeni prije 6-8 godina s dvije doze različitog surogata cjepiva H5N koje je imalo istu formulaciju kao AFLUNOV, ali je sadržavalo soj H5N3.
AFLUNOV may be co-administered with non-adjuvanted seasonal influenza vaccines, and immunisation should be carried out on separate limbs.
Cjepivo AFLUNOV se može primijeniti istodobno s neadjuvantiranim cjepivima protiv sezonske influence a imunizacija se mora provesti na različitim udovima.
Immunocompromised N=143
Imunološki kompromitirani N=143
No increase in reactions was reported when a booster dose was administered 6 months-18 months later, after the initial dosing series.
Nije prijavljeno nikakvo povećanje reakcija kod primjene booster doze 6-18 mjeseci nakon početne serije cijepljenja.
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 imunološki odgovor na virus A/Indonesia/5/2005 (klada 2.1) bio je uočljiv u studiji V87P11 nakon drugog cijepljenja, upućujući na križnu reaktivnost za soj klade 2.2.1 iz cjepiva i sojeve klade 2.1.
PSUR submission when AFLUNOV is used during an influenza pandemic:
Periodička izvješća o neškodljivosti lijeka (PSUR-evi) Podnošenje PSUR-eva kad se AFLUNOV koristi tijekom pandemije influence:
Active immunisation against H5N1 subtype of Influenza A virus.
Aktivna imunizacija protiv podtipa H5N1 virusa influence A.
What you need to know before you receive AFLUNOV You should not receive AFLUNOV:
Što morate znati prije nego primite AFLUNOV
Injection 3
Injekcija 3
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).
Ova indikacija temelji se na podacima o imunogenosti u zdravih ispitanika u dobi od 18 godina naviše nakon primjene dviju doza cjepiva koje sadrži A/turkey/Turkey/1/2005 (H5N1)-sličan soj (vidjeti dio 4.4 i 5.1).
The following adverse events were reported from post-marketing surveillance with Focetria (an H1N1 pandemic vaccine similar to AFLUNOV) which contains the same amount of adjuvant MF59C.1 as AFLUNOV, approved for use in children 6 months of age and above, adults and the elderly:
Sljedeći štetni događaji prijavljeni su tijekom praćenja nakon stavljanja u promet cjepiva Focetria (pandemijskog cjepiva protiv H1N1 sličnog cjepivu AFLUNOV) koji sadrži jednaku količinu adjuvanta MF59C.1 kao i cjepivo AFLUNOV, odobrenog za primjenu u djece u dobi od 6 mjeseci i starije, odraslih i starijih osoba.
Results are shown by SRH.
Rezultati su prikazani SRH vrijednostima.
A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms** per 0.5 ml dose
A/turkey/Turkey/1/2005 (H5N1)-sličan soj (NIBRG-23) (klada 2.2.1) 7,5 mikrograma** po dozi od 0,5 ml
Potassium chloride (E508) Potassium dihydrogen phosphate (E340) Disodium phosphate dihydrate (E339) Magnesium chloride hexahydrate (E511) Calcium chloride dihydrate (E 509) Sodium citrate (E311) Citric acid (E330)Water for injections.
natrijev klorid kalijev klorid (E508) kalijev dihidrogenfosfat (E340) natrijev hidrogenfosfat dihidrat (E339) magnezijev klorid heksahidrat (E511) kalcijev klorid dihidrat (E509) natrijev citrat (E311) citratna kiselina (E330) voda za injekcije
A slight increase in reactions in adults was reported when a booster dose was administered 18 months after the initial dosing series.
Blago povećanje reakcija u odraslih osoba prijavljeno kod primjene booster doze 18 mjeseci nakon početne serije cijepljenja.
How to store AFLUNOV
Kako čuvati AFLUNOV
A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms haemagglutinin
A/turkey/Turkey/1/2005 (H5N1)-sličan soj (NIBRG-23) (klada 2.2.1) 7,5 mikrograma hemaglutinina
• Urticaria (hives)
• Urtikariju (koprivnjaču)
Medical conditions
Medicinsko stanje
Two doses of AFLUNOV were administered three weeks apart to 156 healthy adultsImmunogenicity was assessed in 149 subjects.
Dvije doze cjepiva AFLUNOV primijenjene su s razmakom od tri tjedna u 156 zdravih odraslih osoba.
Gently shake before use.
Lagano protresti prije primjene.
MN results for the three clinical studies in the Table above revealed a seroprotection rate and seroconversion rate against A/turkey/Turkey/2005 ranging from 10% (2-27) to 39% (32-46) and 10% (2-27) to 36% (29-43) respectively.
Rezultati MN analize za tri klinička ispitivanja u gornjoj tablici pokazali su stopu seroprotekcije na virus A/turkey/Turkey/2005 u rasponu od 10% (2-27) do 39% (32-46) te stopu serokonverzije od 10% (2-27) do 36% (29-43).
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%).
neovisno o dobi i zdravstvenom stanju: dijarea (do 11,9%), gubitak apetita (do 10,9%) i povraćanje (do 1,7%).
A phase II clinical trial (V87P1) was conducted with AFLUNOV (A/Vietnam/1194/2004) in 312 healthy adults.
Kliničko ispitivanje faze II (V87P1) provedeno je s cjepivom AFLUNOV (A/Vietnam/1194/2004 na 312 zdravih odraslih osoba.
Gastrointestinal disorders Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Poremećaji probavnog sustava Gastrointestinalni poremećaji poput mučnine, povraćanja, boli u abdomenu i dijaree
After 3 weeks from the 2nd vaccination (day 43) all age groups (i.e. 6-35 months, 3-8 years and 9-17 years) achieved high levels of antibodies to (A/Vietnam/1194/2004) as evaluated with SRH and HI assays as presented in table below.
Tri tjedna nakon 2. cijepljenja (43. dan) sve dobne skupine (tj. 6-35 mjeseci, 3-8 godina i 9-17 godina) postigle su visoke razine protutijela na virus (A/Vietnam/1194/2004), što je procijenjeno SRH i HI analizama i prikazano u tablici u nastavku.
AFLUNOV injection H5N1 Zoonotic influenza vaccine IM
AFLUNOV injekcija Cjepivo protiv zoonozne influence H5N1 i.m.
• Rash or swelling of the skin and mucous membranes
• Osip ili oticanje kože i sluznica
Immunogenicity of AFLUNOV (A/turkey/Turkey/1/2005) in adults (18 to 60 years) and elderly (>61 years) subjects with underlying medical conditions (Study V87_25) or immunosuppressive conditions (mainly HIV-infected subjects) (Study V87_26) in comparison to healthy adults (18-60 years) and elderly (>61 years), was evaluated in two randomised, phase III controlled clinical trials (with a seasonal trivalent inactivated MF59-adjuvanted subunit influenza vaccine approved for use in elderly subjects 65 years of age and older as a comparator).
Imunogenost cjepiva AFLUNOV (A/turkey/Turkey/1/2005) u odraslih (18-60 godina) i starijih (≥61 godina) ispitanika kod kojih postoji patološko stanje (Ispitivanje V87_25) ili stanje imunosupresije (uglavnom ispitanici s HIV-infekcijom) (Ispitivanje V87_26) u usporedbi sa zdravim odraslim osobama (18-60 godina) i osobama starije dobi (≥61 godina), procjenjivana je u dva randomizirana kontrolirana klinička ispitivanja faze III (sa sezonskim trovalentnim inaktiviranim MF59-adjuvantiranim podjediničnim cjepivom protiv influence odobrenim za primjenu u starijih ispitanika u dobi od 65 godina i starijih kao komparatora).
Adults (18-59 years)a
Odrasli (18-59 godina) a
If administration of AFLUNOV with other vaccines can not be avoided, the vaccines should be injected into separate limbs.
Ako se primjena cjepiva AFLUNOV s ostalim cjepivima ne može izbjeći, cjepiva treba injicirati u suprotne udove.
Elderly years)*
Starije osobe godina)*
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.
Podaci za djecu i adolescente upućuju na nešto manji broj nuspojava nakon druge doze cjepiva,
Study V87_25
Studija V87_25
Study V87_26
Studija V87_26
Immune response to vaccination assessed by MN assay is in line with results obtained with SRH.
Imunološki odgovor na cijepljenje procijenjen MN analizom u skladu je s rezultatima dobivenim SRH analizom.
“Possible side effects” may affect the ability to drive or use machines.
Neke od nuspojava spomenutih u dijelu 4. "Moguće nuspojave" mogu utjecati na sposobnost upravljanja vozilima ili rada na strojevima.
Adverse reactions in special populations have been evaluated in two clinical trials, V87_25 and V87_26, involving adult (18-60 years) and elderly (≥ 61 years) subjects who were either healthy or with underlying medical conditions or immunosuppressive conditions.
Klinička ispitivanja u posebnim populacijama bolesnika Nuspojave u posebnim populacijama procjenjivane su u dva klinička ispitivanja, V87_25 i V87_26, koja su uključivala odrasle ispitanike (18-60 godina) i ispitanike starije dobi (≥61 godine) koji su bili ili zdravi ili su imali postojeće medicinsko stanje ili stanje imunosupresije.
Excipient with known effect: The vaccine contains 1.899 milligrams of sodium and 0.081 milligrams of potassium per 0.5 ml dose.
Cjepivo sadrži 1,899 miligrama natrija i 0,081 miligrama kalija po dozi od 0,5 ml.
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Površinski antigeni virusa influence (hemaglutinin i neuraminidaza)* soja:
AFLUNOV is a suspension for injection in a pre-filled syringe.
AFLUNOV je suspenzija za injekciju u napunjenoj štrcaljki.
• Aching muscles
• Bol u mišićima
In a phase I clinical trial (V87P3) adult subjects aged 18-65 years primed 6-8 years previously with 2 doses of MF59-adjuvanted H5N3 vaccine/A/Duck/Singapore/97, were administered 2 booster doses of AFLUNOV (A/Vietnam/1194/2004).
U kliničkom ispitivanju faze I (V87P3) odrasli ispitanici u dobi od 18 do 65 godina koji su primarno cijepljeni pred 6-8 godina s 2 doze MF59-adjuvantiranog cjepiva H5N3/A/Duck/Singapore/97, primili su 2 booster doze cjepiva AFLUNOV (A/Vietnam/1194/2004).
If you have any further questions on the use of this medicinal product, ask your doctor or nurse.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili medicinskoj sestri.
Immune response to vaccination assessed by MN assay is similar to SRH results.
Imunološki odgovor na cijepljenje procijenjen MN analizom sličan je rezultatima SRH analize.
General disorders and administration site conditions Extensive swelling of injected limb lasting more than one week, injection-site cellulitis-like reaction (some cases of swelling, pain, and redness extending more than 10 cm and lasting more than 1 week).
Prekomjerno oteknuće ekstremiteta u koji je ubrizgano cjepivo, a koje traje duže od jednog tjedna, reakcija nalik celulitisu na mjestu injekcije (nekoliko slučajeva oteknuća, bola i crvenila na mjestu injekcije, veličine preko 10 cm i s trajanjem dužim od jednog tjedna) Pedijatrijska populacija
In a clinical trial evaluating 4 different vaccination schedules in 240 subjects 18 to 60 years of age, where the second dose occurred either 1, 2, 3 or 6 weeks after the first AFLUNOV
U kliničkom ispitivanju kojim su se procjenjivala 4 različita rasporeda cijepljenja na 240 ispitanika u dobi od 18 do 60 godina, gdje je druga doza primijenjena 1, 2, 3 ili 6 tjedana nakon prve doze cjepiva AFLUNOV (A/Vietnam/1194/2004).
MedDRA System Organ class Very common
MedDRA klasifikacija organskih sustava
Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
Cjepivo protiv zoonozne influence (H5N1) (površinski antigen, inaktivirano, adjuvantirano).
Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Cjepivo protiv zoonozne influence (H5N1) (površinski antigen, inaktivirano, adjuvantirano)
Immune response to AFLUNOV A/Vietnam/1194/2004 (H5N1) and A/turkey/Turkey/1/2005 (H5NI)
Imunološki odgovor na cjepivo AFLUNOV A/Vietnam/1194/2004 (H5N1) i A/turkey/Turkey/1/2005 (H5N1)
Lung damage was reduced in vaccinated groups.
U cijepljenim je skupinama smanjeno oštećenje pluća.
Milky-white liquid.
Mliječnobijela tekućina.