natgillin/translations-raw huggingface dataset:
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:
Pri spremljanju v obdobju trženja so poročali o naslednjih neželenih učinkih pri sezonskih trivalentnih cepivih brez adjuvansov v vseh starostnih skupinah in pri sezonskem trivalentnem komponentnem cepivu z adjuvansom MF59, ki je odobreno za uporabo pri starejših osebah, starih 65 let in več:
Immunization shall be postponed in patients with febrile illness or acute infection.
Imunizacijo pri bolnikih s povišano telesno temperaturo ali akutno okužbo je treba preložiti.
In the elderly, the reported reactions increased with the third booster dose only when compared with the second dose.
Pri starejših osebah je bilo pri tretjem obnovitvenem odmerku več poročil o reakcijah le v primerjavi z drugim obnovitvenim odmerkom.
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.
Po 3 tednih od 2. cepljenja (43. dan) so vse starostne skupine (tj. 6-35 mesecev, 3-8 let in 9-17 let) dosegle visoko raven protiteles na sev (A/Vietnam/1194/2004), ocenjeno s testoma SRH in HI, kot je predstavljeno v spodnji preglednici.
Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
Obvestite zdravnika ali medicinsko sestro, če imate motnjo strjevanja krvi ali ste nagnjeni k podplutbam.
Immune response to vaccination assessed by MN assay is in line with results obtained with SRH.
Imunski odziv na cepljenje, ocenjeno s testom MN, je v skladu z rezultati, pridobljenimi s SRH.
The vaccine should be allowed to reach room temperature before use.
Pred uporabo počakajte, da cepivo doseže sobno temperaturo.
No data are available in children aged less than 6 months.
Podatkov pri otrocih, starih do 6 mesecev, ni na voljo.
No increase in reactions was reported when a booster dose was administered 6 months-18 months later, after the initial dosing series.
Niso poročali o povečanju števila neželenih učinkov ob dajanju tretjega odmerka 6 mesecev-18 mesecev kasneje po seriji začetnih odmerkov.
Vascular disorders Vasculitis with transient renal involvement.
Žilne bolezni Vaskulitis s prehodno vpletenostjo ledvic
Injection 2
2. injekcija
Your doctor needs to assess the benefits and potential risks of giving you the vaccine.
Vaš zdravnik bo presodil razmerje med koristmi in možnimi tveganji cepljenja.
If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs.
Če je potrebna sočasna uporaba z drugim cepivom, je treba imunizacijo opraviti na drugi okončini.
SRH seroprotection rates ranged from 86% to 98%, seroconversion rated from 64% to 90%, and GMR ranged from 2.92 to 4.57.
98 %, stopnje serokonverzije so bile v razponu od 64 % do 90 % in GMR je bilo v razponu od 2,92 do 4,57.
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).
Pojavnost neželenih učinkov pri cepivu AFLUNOV (A/Vietnam/1194/2004) so ovrednotili v enem kliničnem preskušanju (V87P6) pri otrocih (starih od 6 mesecev do 17 let).
Injection 1
1. injekcija
Two doses of AFLUNOV were administered three weeks apart and a third dose 12 months following the first dose.
V časovnem presledku treh tednov so dali dva odmerka cepiva AFLUNOV in tretji odmerek 12 mesecev po prvem odmerku.
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).
Cepivo AFLUNOV je bilo ovrednoteno pri zdravih odraslih (starih med 18 in 60 let) in zdravih starejših odraslih (starih več kot 60 let) po režimu primarnega cepljenja 1. in 22. dan in obnovitveno cepljenje (glejte poglavji 4.8 in 5.1).
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.
Tako kot pri vseh cepivih, ki se injicirajo, je treba zagotoviti ustrezno obliko zdravljenja in zdravniškega nadzora, ki bi bila v primeru anafilaktične reakcije na cepljenje nemudoma na voljo.
Data obtained in adults showed that AFLUNOV can be given at the same time as non-adjuvanted seasonal influenza vaccines.
Podatki, pridobljeni pri odraslih, kažejo, da se lahko cepivo AFLUNOV daje sočasno s sezonskimi cepivi proti gripi, ki ne vsebujejo adjuvansa.
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).
Obsežna, več kot 1 teden trajajoča oteklina okončine, v katero je bilo injicirano cepivo; celulitisu podobna reakcija na mestu injiciranja (nekaj primerov otekline, bolečine in rdečine na območju več kot 10 cm in s trajanjem več kot 1 teden).
1.175 milligrams per 0.5 ml sorbitan trioleate
1,175 miligrama na 0,5 ml sorbitantrioleat
Toddlers (6-<36 months)
Malčki (6-< 36 mesecev)
* Seroprotection: SRH area ≥ 25 mm2
* Serozaščita: površina SRH ≥ 25 mm2.
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.
Eno cepljenjem s cepivom AFLUNOV (A/Vietnam/1194/2004) je povzročilo visok in hiter serološki odziv pri osebah, ki so bile 6-8 let pred tem primarno imunizirane z dvema odmerkoma različnih nadomestnih cepiv za H5N, z enako formulacijo kot cepivo AFLUNOV, a s sevom H5N3.
Protection against influenza There is no immune correlate of protection established for influenza A (H5N1).
Povezava med imunskim odzivom in zaščito pred gripo tipa A (H5N1) ni znana.
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) dinatrijev hidrogenfosfat (E339) magnezijev klorid heksahidrat (E511) kalcijev klorid dihidrat (E509) natrijev citrat (E311) citronska kislina (E330) voda za injekcije
If administration of AFLUNOV with other vaccines can not be avoided, the vaccines should be injected into separate limbs.
Če se cepljenju s cepivom AFLUNOV hkrati z drugimi cepivi ni mogoče izogniti, je treba cepivi injicirati vsako v svojo okončino.
a actual age range of population enrolled
a dejanski razpon starosti vključene populacije
Medical Conditions N=140
Bolezenska stanja N = 140
What AFLUNOV looks like and contents of the pack
Izgled cepiva AFLUNOV in vsebina pakiranja
• Diarrhoea
• diareja.
Side effects from clinical study in children (6 months to 17 years of age) General side effects reported very commonly in the 6 months to 35 months of age group were injection site redness, muscle ache, irritability and unusual crying.
Splošni neželeni učinki, ki so jih v skupini otrok, starih med 6 in 35 meseci opazili zelo pogosto, so bili pordelost na mestu injiciranja, bolečine v mišicah, razdražljivost in neobičajen jok.
In case of any particles and/or abnormal appearance, the vaccine should be discarded.
Če v cepivu opazite delce in/ali je njegov videz neobičajen,
1 pre-filled syringe (0.5 ml) 10 pre-filled syringes (0.5 ml)
suspenzija za injiciranje 1 napolnjena injekcijska brizga (0,5 ml) 10 napolnjenih injekcijskih brizg (0,5 ml)
Cross-reactive immune response elicited by A/turkey/Turkey/1/2005 against A/Indonesia/5/2005 and A/Vietnam/1194/2004
Navzkrižni imunski odziv, ki ga je izzval A/turkey/Turkey/1/2005, na A/Indonesia/5/2005 in A/Vietnam/1194/2004
The vaccine will be injected into the muscles of the upper arm (deltoid muscle).
Cepivo se injicira v mišico nadlakti (v deltoidno mišico).
• Urticaria (hives)
• urtikarija (koprivnica).
Skin and subcutaneous tissue disorders Erythema multiforme.
Bolezni kože in podkožja Multiformni eritem
V87P11 Elderly (>61-89 years)a N=142
V87P11 starejši (61-89 let) N = 142
Any Other Adverse Event
vsi drugi neželeni učinki
The European Medicines Agency has deferred the obligation to submit the results of studies with AFLUNOV in one or more subsets of the paediatric population in active immunisation against H5N1 subtype of Influenza A virus.
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s cepivom AFLUNOV za eno ali več podskupin pediatrične populacije za aktivno imunizacijo proti podtipu H5N1 virusa influence A. Za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.
Other medicines and AFLUNOV
Druga zdravila in cepivo AFLUNOV
Blood and lymphatic system disorders Thrombocytopenia (in some cases reversible platelet counts less than 5000 mm3).
Trombocitopenija (v nekaterih primerih se število trombocitov zmanjša na manj kot 5000/mm³ in je reverzibilno)
Adults (18-60 years)
Odrasli (18-60 let)
Information from non-clinical studies
Informacije iz predkliničnih študij
Fainting can occur following, or even before, any needle injection.
Po katerem koli injiciranju z iglo ali celo pred njim se lahko pojavi omedlevica.
Active immunisation against H5N1 subtype of Influenza A virus.
Aktivna imunizacija proti virusu influence A podtipa H5N1.
AFLUNOV may be co-administered with non-adjuvanted seasonal influenza vaccines, and immunisation should be carried out on separate limbs.
Cepivo AFLUNOV se lahko daje sočasno s sezonskimi cepivi proti gripi brez adjuvansa, pri čemer je treba imunizacijo opraviti na drugi okončini.
Some degree of cross-reactive immunity has been observed against H5N1 viruses of clades different to that of the vaccine strain.
V kliničnih preskušanjih so opazili določeno stopnjo navzkrižnih imunskih odzivov na viruse H5N1 iz gruč, drugačnih kot pri cepilnem sevu.
In this trial no vaccine related SAEs were observed.
V tem preskušanju niso opazili neželenih učinkov, povezanih s cepivom.
Immune response to AFLUNOV A/Vietnam/1194/2004 (H5N1) and A/turkey/Turkey/1/2005 (H5NI)
Imunski odziv na AFLUNOV A/Vietnam/1194/2004 (H5N1) in A/turkey/Turkey/1/2005 (H5N1)
Uncommon (≥1/1,000 to
Redki (≥ 1/10.000 do
One dose of 0.5 ml will be given.
Prejmejo en odmerek 0,5 ml.
There is limited experience in children between 6 months and 17 years of age.
Otroci, stari od 6 mesecev do 17 let Pri otrocih, starih med 6 meseci in 17 leti, so izkušnje omejene.
Elderly (>61 years)
Starejši (≥ 61 let)
A clinical trial (V87P6) was conducted with AFLUNOV (A/Vietnam/1194/2004) in 471 children from 6 months to 17 years of age.
Opravili so klinično preskušanje (V87P6) za cepivo AFLUNOV (A/Vietnam/1194/2004) pri 471 otrocih, starih od 6 mesecev do 17 let.
In addition, higher rates of arthralgia (up to 23.3%) were reported in both adult and elderly subjects, who were immunocompromised or with underlying medical conditions.
Poleg tega so pri odraslih in starejših osebah, ki so imele oslabljen imunski sistem ali z osnovna bolezenska stanja, poročali o višjih stopnjah artralgije (do 23,3 %).
If you have any further questions on the use of this medicinal product, ask your doctor or nurse.
Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom ali medicinsko sestro.
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).
V kliničnem preskušanju I. faze (V87P3) so odrasle osebe, stare 18-65 let, ki so 6-8 let pred tem prejele 2 primarna odmerka cepiva H5N3 A/Duck/Singapore/97 z adjuvansom MF59, prejele 2 obnovitvena odmerka cepiva AFLUNOV (A/Vietnam/1194/2004).
What you need to know before you receive AFLUNOV You should not receive AFLUNOV:
Kaj morate vedeti, preden boste cepljeni s cepivom AFLUNOV S cepivom AFLUNOV ne smete biti cepljeni:
In a third clinical trial (V87P11) 194 adult subjects were enrolled and received two doses of AFLUNOV (A/turkey/Turkey/1/2005) administered three weeks apart.
V tretjem kliničnem preskušanju (V87P11) je bilo vključenih 194 odraslih oseb, ki so prejele dva odmerka cepiva AFLUNOV (A/turkey/Turkey/1/2005), dana s tritedenskim presledkom.
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1 and to residues (eggs and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide).
Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaktične reakcije) na učinkovino, katerokoli pomožno snov, navedeno v poglavju 6.1, ali snov v sledovi (jajčne ali piščančje beljakovine, ovalbumin, kanamicinsulfat, neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid).
MN results for A/Indonesia/5/2005 revealed a seroprotection rate of 38% (31-45) in adults (18-60 years) and 14% (8-20) in elderly (>61 years); a seroconversion rate of 58% (50-65) in adults and 30% (23-38) in elderly and finally a GMR of 4.67 (3.95-5.56) in adults and 2.19 (1.86-2.58) in elderly.
Rezultati MN za A/Indonesia/5/2005 so pokazali stopnjo serozaščite 38 % (31-45) za odrasle (18-60 let) in 14 % (8-20) za starejše (≥ 61 let); stopnjo serokonverzije 58 % (50-65) za odrasle in 30 % (23-38) za starejše ter končno GMR 4,67 (3,95-5,56) za odrasle in 2,19 (1,86-2,58) za starejše.
AFLUNOV contains sodium and potassium.
Cepivo AFLUNOV vsebuje natrij in kalij.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Če bolnik prejema imunosupresivna zdravila, je lahko imunski odziv manjši.
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 cepiva AFLUNOV (A/turkey/Turkey/1/2005) pri odraslih (18-60 let) in starejših osebah (≥ 61 let) z osnovnimi bolezenskimi stanji (študija V87_25) ali zmanjšanim imunskim odzivom (večinoma osebe, okužene s HIV) (študija V87_26) v primerjavi z zdravimi odraslimi (18-60 let) in starejšimi osebami (≥ 61 let) so ocenili v dveh randomiziranih, nadzorovanih kliničnih preskušanjih
Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
zoonotsko cepivo proti gripi (H5N1) (s površinskimi antigeni, inaktivirano, z adjuvansom)
Contents of the pack and other information What AFLUNOV contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo AFLUNOV
• Aching muscles
• bolečine v mišicah,
In such cases, you should be aware that the side effects may be more intense.
V takih primerih so lahko neželeni učinki okrepljeni.
Rare (affects 1 to 10 users in 10.000):
Občasni (pojavijo se pri 1 do 10 od 1.000 bolnikov):
Blood and lymphatic system disorders Lymphadenopathy.
Bolezni krvi in limfatičnega sistema
Headache, dizziness, somnolence, syncope.
Bolezni živčevja Glavobol, omotičnost, zaspanost, sinkopa.
Method of administration Immunisation should be carried out by intramuscular injection into the deltoid muscle.
Imunizacija se opravi z intramuskularnim injiciranjem v deltoidno mišico.
In Study V87P11 MN results against homologous A/turkey/Turkey/1/2005) indicate a seroprotection and seroconversion rate of 85% (79-90) and 93% (89-96), respectively.
V študiji V87P11 kažejo rezultati MN proti homolognemu A/turkey/Turkey/1/2005 na stopnjo serozaščite 85 % (79-90) in stopnjo serokonverzije 93 % (89-96).
In addition, two large observational studies designed to assess the safety of Focetria exposure in pregnancy showed no increase in the rates of gestational diabetes, preeclampsia, abortions, stillbirth, low birth weight, prematurity, neonatal deaths, and congenital malformations among almost 10,000 vaccinated pregnant women and their offspring compared with unvaccinated controls.
Poleg tega dve veliki opazovalni študiji, zasnovani za oceno varnosti izpostavljenosti cepivu Focetria med nosečnostjo, nista pokazali zvišanja stopenj gestacijskega diabetesa, preeklampsije, splavov,
Nervous system disorders Neurological disorders, such as encephalomyelitis, and Guillain Barré syndrome.
Nevrološke bolezni, kot sta encefalomielitis in Guillain-Barréjev sindrom
The potential benefits to the mother and risks to the infant should be considered before administering AFLUNOV during breast-feeding.
AFLUNOV je treba pretehtati možne koristi za mater in tveganja za otroka Plodnost
• Rash or swelling of the skin and mucous membranes
• izpuščajem ali oteklino kože in sluznic,
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)** Seroconversion factor (95%CI)*** a Ages 62-88 years; b Ages 61-68 years; c Ages 61-89 years * Seroprotection: SRH area ≥ 25 mm2
Faktor serokonverzije (95-odstotni IZ)*** a Starost 62-88 let; b starost 61-68 let; c starost 61-89 let.
Post-marketing surveillance No post-marketing surveillance data are available following AFLUNOV administration.
Podatkov iz spremljanja v obdobju trženja za cepivo AFLUNOV ni.
ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
Adolescents (9-<18 years)
Mladostniki (9-< 18 let)
** Seroconversion was defined as an SRH area ≥25 mm2 for subjects who were seronegative at baseline (Day 1 SRH area ≤4 mm2) or a significant (at least 50%) increase in SRH area for subjects who were seropositive at baseline (Day 1 SRH area >4 mm2) *** GMRs of SRH
** Serokonverzija je bila opredeljena kot površina SRH ≥ 25 mm2 pri osebah, ki so bile ob izhodišču seronegativne (1. dan površina SRH ≤ 4 mm2), ali kot pomembno (vsaj 50-%)
AFLUNOV injection H5N1 Zoonotic influenza vaccine IM
AFLUNOV injekcije zoonotsko cepivo proti gripi (H5N1) i.m.
AFLUNOV(A/Vietnam/1194/2004) and an AFLUNOV-like H5N1 vaccine (A/turkey/Turkey/1/2005-like) were tested.
Testirali so cepivo AFLUNOV (A/Vietnam/1194/2004) in cepivo H5N1, podobno cepivu AFLUNOV (sev podoben A/turkey/Turkey/1/2005).
Elderly years)*
IZ)**
• Disorders of the gut such as
• Črevesne motnje, kot so:
• Pain at the site of injection
bolečina na mestu injiciranja,
Very commonly reported reactions in the 36 months to 17 years of age group were pain, headache and fatigue.
Neželeni učinki, ki so se v skupini otrok, starih med 36 meseci in 17 leti, opazili zelo pogosto, so bili bolečina,
A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms** per 0.5 ml dose
sevu A/turkey/Turkey/1/2005 (H5N1) podobnega seva (NIBRG-23) (gruča 2.2.1) 7,5 mikrogramov** na 0,5 ml odmerek
Since a second dose is recommended, it should be noted that there are no safety, immunogenicity or efficacy data to support interchangeability of AFLUNOV with other H5N1 monovalent vaccines.
imunogenosti ali učinkovitosti, ki podpirajo zamenljivost cepiva AFLUNOV z drugimi monovalentnimi cepivi H5N1.
Common (≥1/100 to <1/10)
Pogosti (≥ 1/100 do
Musculoskeletal and connective tissue disorders
angioedem Bolezni mišično-skeletnega sistema in vezivnega tkiva
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 podlagi podatkov, pridobljenih iz preskušanj V87P1, V87P11 in V87_13 so ocenili obstojnost protiteles po primarnem cepljenju pri starejših osebah, in sicer s testi HI, SRH in MN.
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.
Cepivo AFLUNOV je namenjeno za uporabo pri odraslih osebah, starih 18 let ali več, ki se daje v primeru izbruhov zoonotskih virusov gripe (ki jih prenašajo ptice), ki bi lahko povzročili pandemijo.
and a type of paralysis known as Guillain-Barré Syndrome.
• Nevrološke motnje, kot so encefalomielitis (vnetje osrednjega živčevja) in vrsta paralize, znana kot Guillain-Barréjev sindrom.
AFLUNOV is a suspension for injection in a pre-filled syringe.
Cepivo AFLUNOV je suspenzija za injiciranje v napolnjeni injekcijski brizgi.
To be administered intramuscularly into the deltoid muscle.
Daje se intramuskularno v deltoidno mišico.
Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Nevrološke težave, kot so nevralgija, parestezija,
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide) of this vaccine.
Anafilaktične (tj. življenjsko nevarne) reakcije v anamnezi na katerokoli sestavino cepiva ali ostanke v sledeh (jajčne in kokošje beljakovine, ovalbumin, kanamicinsulfat, neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid) v cepivu.
% SC (95% CI) Day 43
% SZ (95-odstotni IZ) 43. dan
AFLUNOV suspension for injection in pre-filled syringe.
AFLUNOV suspenzija za injiciranje v napolnjeni injekcijski brizgi.
GMR (95% CI) Day 43 to Day 1
GMR (95-odstotni IZ) 43. dan do 1. dan % SK (95-odstotni IZ) 43. dan
Medical Conditions N=143
Bolezenska stanja N = 143
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:
(pandemsko cepivo H1N1, podobno cepivu AFLUNOV), ki vsebuje enako količino adjuvansa MF59C.1 kot cepivo AFLUNOV in je odobreno za uporabo pri otrocih, starih6 mesecev in več, odraslih in starejših bolnikih:
There are no data on co-administration of AFLUNOV with vaccines other than non-adjuvanted seasonal influenza vaccines.
Podatkov o sočasni uporabi cepiva AFLUNOV s cepivi, ki niso sezonska cepiva proti gripi brez adjuvansa, ni.
Contents of the pack and other information
Shranjevanje cepiva AFLUNOV Vsebina pakiranja in dodatne informacije
MN results for A/Vietnam/1194/2004 revealed a seroprotection rate of 10% (6-16) in adults (18-60 years) and 6% (3-11) in elderly (>61 years); a seroconversion rate of 19% (13-25) in adults and 7% (4-13) in elderly and finally a GMR of 1.86 (1.63-2.12) in adults and 1.33 (1.17-1.51) in elderly.
(18-60 let) in 6 % (3-11) za starejše (≥ 61 let); stopnjo serokonverzije 19 % (13-25) za odrasle in 7 % (4-13) za starejše ter končno GMR 1,86 (1,63-2,12) za odrasle in 1,33 (1,17-1,51) za starejše.
In Study V87P11, MN results against homologous A/turkey/Turkey/1/2005 indicate a seroprotection and seroconversion rate of 68% (59-75) and 81% (74-87), respectively.
V študiji V87P11 kažejo rezultati MN proti homolognemu A/turkey/Turkey/1/2005 na stopnjo serozaščite 68 % (59-75) in stopnjo serokonverzije 81 % (74-87).