natgillin/translations-raw huggingface dataset:
• The active ingredient in CELSENTRI is maraviroc.
• Zdravilna učinkovina v zdravilu CELSENTRI je maravirok.
CELSENTRI film-coated tablets are blue coloured with “ Pfizer” on one side and “ MVC 150” or “ MVC 300” on the other.
Filmsko obložene tablete CELSENTRI so modre barve, z oznako “ Pfizer ” na eni strani in “ MVC 150 ” ali “ MVC 300 ” na drugi strani.
CELSENTRI 150 mg and 300 mg film-coated tablets are supplied in bottles of 180 tablets or in blister packs of 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) film-coated tablets.
Filmsko obložene tablete CELSENTRI 150 mg in 300 mg so na voljo v plastenkah, ki vsebujejo 180 tablet, ali v pretisnih omotih, ki vsebujejo 30, 60 ali 90 tablet ter v dvojnem pakiranju s 180 (2 pakiranji po 90) filmsko obloženimi tabletami.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, Velika Britanija.
The Manufacturer is:
Izdelovalec:
Gödecke GmbH (a pharma plant of Pfizer GmbH), Mooswaldallee 1, 79090 Freiburg, Germany.
Gödecke GmbH (tovarna družbe Pfizer GmbH), Mooswaldallee 1, 79090 Freiburg, Nemčija.
61 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Lietuva Pfizer Luxembourg SARL, filialas Lietuvoje Tel: +3705 2514000
66 Lietuva Pfizer Luxembourg SARL, filialas Lietuvoje Tel: +3705 2514000
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /.
It contains influenza (flu) viruses that have been inactivated (killed).
Vsebuje dele virusov gripe, ki so bili inaktivirani (uničeni).
Celvapan contains a flu strain called A/ VietNam/ 1203/ 2004 (H5N1).
Zdravilo Celvapan vsebuje sev gripe, imenovan A/ VietNam/ 1203/ 2004 (H5N1).
Celvapan is a vaccine to prevent ‘ pandemic’ flu.
Zdravilo Celvapan je cepivo proti pandemični gripi.
A flu pandemic happens when a new type (strain) of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it.
Pandemija gripe nastopi, ko se pojavi nov sev virusa gripe, ki se zlahka širi med ljudmi, ker ti nanj niso imuni (zaščiteni proti njemu).
Celvapan would be given according to official recommendations.
Zdravilo Celvapan se daje v skladu z uradnimi priporočili.
Celvapan has been studied in adults, including the elderly (above 60 years of age).
Zdravilo Celvapan so proučevali pri odraslih, vključno s starostniki (starejšimi od 60 let).
Celvapan is given by injection into the shoulder muscle in two doses, at least three weeks apart.
Cepivo Celvapan se injicira v hrbtno mišico v dveh odmerkih v razmaku najmanj treh tednov.
Celvapan is a ‘ mock-up’ vaccine.
Zdravilo Celvapan je „ modelno “ cepivo.
This is a special type of vaccine that is designed to help with the management of a pandemic.
To je posebna vrsta cepiva, ki je izdelana za pomoč pri nadzorovanju pandemije.
Before a pandemic starts, nobody knows which strain of flu virus will be involved, so pharmaceutical companies cannot prepare the correct vaccine in advance.
Pred začetkom pandemije ni znano, kateri sev virusa gripe bo razsajal, zato farmacevtska podjetja ne morejo vnaprej pripraviti ustreznega cepiva.
Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune.
Lahko pa pripravijo cepivo, ki vsebuje posebej izbrani sev virusa gripe, ki mu ni bil še nihče izpostavljen in na katerega nihče ni imun.
They can then test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing the pandemic is included.
To cepivo lahko preizkusijo, da bi preverili odziv ljudi nanj, na podlagi česar lahko predvidevajo, kako se bodo ti odzvali, ko se bo pojavil sev gripe, ki povzroča pandemijo.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „ učijo ”, kako naj se brani proti bolezni.
Celvapan contains a virus called H5N1 that has been inactivated (killed) so that it does not cause any disease.
Zdravilo Celvapan vsebuje inaktivirani (uničeni) virus H5N1, ki ne povzroča nobene bolezni.
If a pandemic starts, the virus strain in Celvapan will be replaced by the strain causing the pandemic before the vaccine can be used.
Če izbruhne pandemija, bo sev virusa v zdravilu Celvapan nadomeščen s sevom, ki povzroča pandemijo, preden bo cepivo mogoče uporabljati.
When a person is given the vaccine, the immune system recognises the inactivated virus as ‘ foreign’ and makes antibodies against it.
Ko oseba prejme cepivo, imunski sistem prepozna inaktivirani virus kot tujek in proti njemu razvije protitelesa.
This helps to protect against the disease.
Ta mu bodo pomagala pri obrambi pred boleznijo.
The viruses used in Celvapan are grown in mammal cells (‘ vero cells’), unlike those in some other flu vaccines, which are grown in hen ’ s eggs.
Viruse, ki so uporabljeni v zdravilu Celvapan, gojijo v celicah sesalcev („ celicah Vero “), v nasprotju s tem pa viruse, uporabljene v nekaterih drugih cepivih proti gripi, gojijo v kokošjih jajcih.
The effects of Celvapan were first tested in experimental models before being studied in humans.
Učinki zdravila Celvapan so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The main study of Celvapan included 561 healthy volunteers, 281 of whom were over the age of 60 years.
V glavni študiji zdravila Celvapan je sodelovalo 561 zdravih prostovoljcev, izmed katerih jih je bilo 281 starejših od 60 let.
The study looked at the ability of two 7.5-microgram doses of Celvapan, given 21 days apart, to trigger the production of antibodies (‘ immunogenicity’). The main measures of effectiveness were the levels of antibodies against the flu virus in the blood before vaccination, on the day of the second injection (day 21), and 21 days after the second vaccination (day 42).
Glavno merilo učinkovitosti je bila koncentracija protiteles proti virusu gripe v krvi pred cepljenjem na dan drugega injiciranja (21. dan) in 21 dni po drugem injiciranju (42. dan).
According to criteria laid down by the Committee for Medicinal Products for Human Use (CHMP), a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
V skladu z merili, ki jih je določil Odbor za zdravila za uporabo v humani medicini (CHMP), morajo modelna cepiva, da veljajo kot primerna, zagotoviti zaščitno koncentracijo protiteles pri vsaj 70% ljudi.
The study showed that Celvapan produced an antibody response that met these criteria.
Študija je pokazala, da zdravilo Celvapan izzove odziv protiteles, ki izpolnjuje to merilo.
At 21 days after the second injection, 72% of the adults below 60 years of age (192 out of 265) and 74% of those above 60 years of age (200 out of 270) had levels of antibodies that would protect them against H5N1.
Na 21. dan po drugi injekciji so pri 72% odraslih, mlajših od 60 let (192 od 265), in 74% starejših od 60 let (200 od 270) nastale ravni protiteles, ki bi jih ščitile pred virusom H5N1.
The most common side effect with Celvapan (seen in more than 1 people vaccinated in 10) is pain at the site of the injection.
Najpogostejši neželeni učinek zdravila Celvapan (opažen pri več kot 1 cepljeni osebi izmed 10) je bolečina na mestu injiciranja.
For the full list of all side effects reported with Celvapan, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Celvapan, glejte navodilo za uporabo.
Celvapan should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as formaldehyde, benzonase or sucrose.
Zdravilo Celvapan se ne sme dajati osebam, ki so imele anafilaktično reakcijo (hudo alergijsko reakcijo) na katero koli sestavino zdravila ali na katero koli izmed snovi v sledeh (v zelo nizkih koncentracijah) cepiva, npr. formaldehid, benzonaza ali saharoza.
The CHMP decided that Celvapan’ s benefits are greater than its risks for the prophylaxis of influenza in an officially declared pandemic situation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Celvapan pri preprečevanju gripe pri uradno razglašeni pandemiji večje od z njim povezanih tveganj.
The Committee recommended that Celvapan be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Celvapan odobri dovoljenje za promet.
Celvapan has been authorised under ‘ Exceptional Circumstances’.
Zdravilo Celvapan je bilo odobreno „ v izjemnih okoliščinah “.
This means that because the strain of flu virus that may cause a pandemic is not known, it has not been possible to obtain full information about the future pandemic vaccine.
To pomeni, da zaradi nepoznavanja seva virusa gripe, ki utegne povzročiti pandemijo, ni bilo mogoče pridobiti celotnih podatkov o cepivu za bodočo pandemijo.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo vsako leto pregledala vse razpoložljive nove informacije in po potrebi posodobila ta povzetek.
What information is still awaited for Celvapan?
Katere informacije o zdravilu Celvapan še pričakujemo?
If a pandemic is declared, the company that makes Celvapan will include the flu strain responsible in the vaccine.
Ob razglasitvi pandemije bo družba, ki izdeluje zdravilo Celvapan, v cepivo vključila pandemični sev virusa gripe.
It will then collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Nato bo zbrala informacije o varnosti in učinkovitosti končnega pandemičnega cepiva in jih posredovala CHMP v oceno.
Which measures are being taken to ensure the safe use of Celvapan?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Celvapan?
If Celvapan is used during a pandemic, the company that makes it will collect information on the safety of the vaccine while it is being used.
Če se bo cepivo Celvapan uporabljalo med pandemijo, bo družba, ki ga izdeluje, zbrala informacije o varnosti cepiva med njegovo uporabo.
This will include information on its side effects and its safety in the elderly, pregnant women, patients with severe conditions, and people who have problems with their immune systems.
Te informacije bodo vključevale podatke o njegovih neželenih učinkih ter varnosti njegove uporabe pri starostnikih, nosečnicah, resno bolnih bolnikih in ljudeh, ki imajo težave z imunskim sistemom.
The European Commission granted a marketing authorisation valid throughout the EU for Celvapan to Baxter AG on 04 March 2009.
Evropska komisija je dovoljenje za promet z zdravilom Celvapan, veljavno po vsej Evropski uniji, odobrila družbi Baxter AG dne 04. marca 2009.
The full EPAR for Celvapan can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Celvapan je na voljo tukaj.
7.5 microgram/ 0.5 ml
7. 5 microgram/ 0. 5 ml
CELVAPAN suspension for injection Pandemic influenza vaccine (whole virion, Vero cell derived, inactivated)
CELVAPAN suspenzija za injiciranje Cepivo proti pandemični gripi z inaktiviranimi virusi, pridobljenimi iz celic Vero
Whole virion influenza vaccine, inactivated containing antigen of pandemic strain*:
Cepivo proti gripi z inaktiviranimi virusi, ki vsebuje antigen pandemičnega seva *:
A/ Vietnam/ 1203/ 2004 (H5N1) per 0.5 ml dose
A/ Vietnam/ 1203/ 2004 (H5N1) na odmerek 0, 5 ml
7.5 micrograms**
7, 5 mikrograma **
* propagated in Vero cells (continuous cell line of ** expressed in micrograms haemagglutinin.
* razmnožen v celicah Vero (neprekinjena celična linija sesalskega izvora) ** izraženo v mikrogramih hemaglutinina
See section 6.5 for the number of doses per vial.
Število odmerkov na vialo je navedeno v poglavju 6. 5.
Pandemic influenza vaccine should be used in accordance with official guidance.
Cepivo proti pandemični gripi je treba uporabljati v skladu z uradnimi smernicami.
CELVAPAN has been evaluated in adults 18-59 years of age and in elderly 60 years of age and above.
Cepivo CELVAPAN je bilo preizkušeno pri odraslih, starih od 18 do 59 let, ter pri starostnikih, starih 60 let ali več.
Adults: first dose of 0.5 ml at an elected date.
Odrasli: prvi odmerek 0, 5 ml naj bo injiciran na izbran datum.
There is no data on CELVAPAN vaccination dose and schedule for subjects under 18 years old and for subjects with co-morbidities (e. g. immunosuppressed subjects).
Trenutno ni na voljo nobenih podatkov o odmerku zdravila CELVAPAN in o shemi cepljenja za osebe, ki so mlajše od 18 let, in za osebe z več boleznimi (npr. osebe z oslabljenim imunskim sistemom).
In a pandemic situation administration of the vaccine in those populations shall follow national recommendations.
Pri uradno razglašeni pandemiji je treba pri odmerjanju cepiva pri teh osebah upoštevati nacionalna priporočila.
For further information, see section 5.1.
Za dodatne informacije glejte poglavje 5. 1.
Immunization should be carried out by intramuscular injection into the deltoid muscle.
Cepivo je treba injicirati intramuskularno, v deltoidno mišico.
History of an anaphylactic (i. e. life-threatening) reaction to any of the constituents or trace residues (e. g. formaldehyde, benzonase, sucrose) of this vaccine.
Anafilaksija v pretekli anamnezi (npr. smrtno nevarna) zaradi preobčutljivosti na katerokoli sestavino cepiva ali ostanke v sledeh (npr. formaldehid, Benzonaza, saharoza).
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.
V pandemičnih razmerah je cepljenje morda vseeno upravičeno, vendar ob zagotovitvi opreme za oživljanje, ki mora biti takoj na voljo.
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance(s), to any of the excipients and to trace residues e. g. formaldehyde, benzonase, or sucrose.
Pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaktične reakcije) na zdravilno učinkovino, katerokoli pomožno snov ali ostanke v sledeh, npr. formaldehid, Benzonaza ali saharozo, je treba biti previden.
If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Če pandemične razmere to dopuščajo, je treba cepljenje odložiti pri bolnikih, ki imajo hujše obolenje s povišano telesno temperaturo ali akutno okužbo.
CELVAPAN should under no circumstances be administered intravascularly.
Cepiva CELVAPAN ne smete v nobenem primeru injicirati v žilo.
There are no data with CELVAPAN using the subcutaneous route.
Ni podatkov o subkutanem injiciranju cepiva CELVAPAN.
A protective response may not be induced in all vaccinees (see section 5.1).
Zaščitni odziv morda ne bo dosežen pri vseh cepljenih osebah (glejte poglavje 5. 1).
CELVAPAN should not be given at the same time as other vaccines.
Cepiva CELVAPAN ne uporabljajte hkrati z drugimi cepivi.
Immunoglobulin is not to be given with CELVAPAN.
Cepiva CELVAPAN ne uporabljajte hkrati z imunoglobulini.
If it is necessary to provide immediate protection, CELVAPAN may be given at the same time as normal or specific immunoglobulin.
Če je to nujno za zagotavljanje takojšnje zaščite, pa je dovoljeno zdravilo CELVAPAN injicirati hkrati s polispecifičnim ali specifičnim imunoglobulinom.
Injections of CELVAPAN and immunoglobulin should be made into separate limbs.
CELVAPAN in imunoglobulin injicirajte v različni okončini.
3 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
Data from vaccinations with interpandemic trivalent vaccines in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine.
Podatki o cepljenju nosečnic z interpandemičnimi trivalentnimi cepivi ne kažejo škodljivih vplivov na plod in mater, ki bi lahko bili povezani s cepivom.
Therefore, for pregnant women, administration of the pandemic influenza vaccine is recommended, irrespective of their stage of pregnancy.
Zato je pri nosečnicah priporočljivo cepljenje s cepivom proti pandemični gripi ne glede na obdobje nosečnosti.
The vaccine CELVAPAN may be used during lactation.
Dovoljena je tudi uporaba cepiva CELVAPAN med dojenjem.
4.7 Effects on ability to drive and use machines
3 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Some undesirable effects mentioned under section 4.8 such as dizziness and vertigo may affect the ability to drive or use machines.
Na sposobnost vožnje in upravljanja s stroji lahko vplivajo določeni neželeni učinki, ki so navedeni v poglavju 4. 8, na primer omotica ali vrtoglavica.
In clinical trials with the mock-up vaccine (see section 5.1) in 606 subjects (326 between 18 and 59 years old, and 280 aged 60 and above), the following adverse reactions were assessed as at least possibly related by the investigator.
V kliničnih preskušanjih z modelnim cepivom (glejte poglavje 5. 1) pri 606 osebah (326 v starosti med 18. in 59. letom in 280, starih 60 let ali več) so opazili v nadaljevanju navedene neželene učinke, za katere so ocenili, da so lahko povezani s cepivom.
Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by influenza vaccines.
Večina jih je blagih, kratkotrajnih in glede na zvrst podobnih tistim, ki jih povzročijo cepiva proti gripi.
There were fewer reactions after the second dose of the vaccine compared with the first dose.
Po drugem odmerku cepiva je bilo manj učinkov kot po prvem.
The most frequently occurring adverse reaction was injection site pain, which was usually mild.
Najpogostejši neželeni učinek je bila bolečina na mestu injiciranja, ki je bila po navadi blaga.
Adverse reactions are listed according to the following frequency.
Neželeni učinki so razvrščeni glede na pogostnost.
Not known (cannot be estimated from the available data)
Zelo pogosti (≥1/ 10) Pogosti (≥1/ 100 do < 1/ 10) Občasni (≥1/ 1000 do < 1/ 100) Redki (≥1/ 10. 000 do < 1/ 1. 000) Zelo redki (< 1/ 10. 000) Ni znano (ni mogoče oceniti iz razpoložljivih podatkov)
Infections and infestations U
in parazitske bolezni UInfekcijske
Common: nasopharyngitis
Pogosti: nazofaringitis
Blood and the lymphatic system disorders U
krvi in limfatičnega sistema UBolezni
Psychiatric disorders U
motnje UPsihiatrične
Uncommon: insomnia, restlessness
Občasni: nespečnost, nemir
Nervous system disorders U
živčevja UBolezni
Common: headache, dizziness Uncommon: somnolence, dysaesthesia,
Pogosti: glavobol, omotica Občasni: somnolenca, disestezija
Eye disorders U
bolezni UOčesne
Uncommon: conjunctivitis
Občasni: konjunktivitis
Ear and labyrinth disorders U
bolezni, vključno z motnjami labirinta UUšesne
Common: vertigo Uncommon: sudden hearing loss
Pogosti: vrtoglavica Občasni: nenadna izguba sluha
Vascular disorders U
bolezni UŽilne
Respiratory, thoracic and mediastinal disorders U
dihal, prsnega koša in mediastinalnega prostora UBolezni
4 Common: pharyngolaryngeal pain Uncommon: dyspnoea, cough, rhinorrhoea, nasal congestion
Pogosti: bolečine v žrelu in grlu Občasni: dispneja, kašljanje, izcedek iz nosu (rinoreja), zamašen nos
Gastrointestinal disorders U
prebavil UBolezni
Uncommon: gastro-intestinal symptoms (such as nausea, vomiting, diarrhoea and upper abdominal pain)
Občasni: prebavne težave (kot so slabost, bruhanje, driska in bolečine v zgornjem delu trebuha)
Skin and subcutaneous tissue disorders Common: hyperhidrosis Uncommon: rash, pruritus
Bolezni kože in podkožja Pogosti: hiperhidroza 4 Občasni: izpuščaj, srbečica
Musculoskeletal and connective tissue disorders Common: arthralgia, myalgia
Bolezni mišično- skeletnega sistema in vezivnega tkiva Pogosti: artralgija, mialgija
General disorders and administration site conditions Very common: injection site pain Common: pyrexia, chills, fatigue, malaise, induration, erythema, swelling and haemorrhage at the injection site Uncommon: injection site irritation
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: bolečina na mestu injiciranja Pogosti: pireksija, mrzlica, utrujenost, slabo počutje, induracija, rdečina, otekanje in krvavitev na mestu injiciranja Občasni: draženje na mestu injiciranja
For cell-based influenza vaccines, post-marketing surveillance data are not yet available.
Za cepiva proti gripi, ki so izdelana v celicah, še ni na voljo podatkov o spremljanju po pridobitvi dovoljenja za promet.
From post- marketing surveillance with egg-derived interpandemic trivalent vaccines, the following serious adverse reactions have been reported:
Med spremljanjem interpandemičnih trivalentnih cepiv na osnovi jajc po pridobitvi dovoljenja za promet so poročali o naslednjih resnih neželenih učinkih:
Generalised skin reactions including pruritus, urticaria, and non-specific rash.
Splošne kožne reakcije, vključno s srbečico, urtikarijo in nespecifičnim izpuščajem.
Allergic reactions, in rare cases leading to shock, have been reported.
Nevralgija, parestezije, konvulzije, prehodna trombocitopenija Poročali so o pojavu alergijskih reakcij, ki so v redkih primerih vodile do šoka.
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Nevrološke motnje, kot so encefalomielitis, nevritis in Guillain- Barréjev sindrom.
Influenza vaccines, ATC Code J07BB01
Cepiva proti gripi, oznaka ATC J07BB01
These antigens can be considered as ‘ novel’ antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Te antigene lahko obravnavamo kot » nove « antigene, ki posnemajo pogoje, v katerih ciljna populacija še ni bila cepljena.
Data obtained with the mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with mock-up vaccines are relevant for the pandemic vaccines.
Podatki, pridobljeni z uporabo modelnega cepiva, bodo uporabljeni pri oblikovanju strategije cepljenja, ki bo najverjetneje uporabljena za cepivo proti pandemični gripi: podatki o klinični imunogenosti, varnosti in reaktogenosti, pridobljeni z modelnimi cepivi, veljajo tudi za pandemična cepiva.
5 Immune response against the vaccine strain contained in CELVAPAN (A/ Vietnam/ 1203/ 2004)
Odziv imunskega sistema na sev, ki je v cepivu CELVAPAN (A/ Vietnam/ 1203/ 2004)
The immunogenicity of the 7.5 µg non-adjuvanted formulation of CELVAPAN (strain A/ Vietnam/ 1203/ 2004) has been evaluated in two clinical studies in adults aged 18 – 59 years (N=312) and in elderly subjects aged 60 years and older (N=272) following a 0, 21 day schedule.
Imunogenost 7, 5 µg formulacije cepiva CELVAPAN brez adjuvansa (sev A/ Vietnam/ 1203/ 2004) je bila ocenjena v dveh kliničnih študijah pri odraslih, starih od 18 do 59 let (n=312) in pri starejših osebah, starih 60 let in več (n=272), in sicer po shemi cepljenja prvi in 21. dan.
After primary vaccination the seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in adults aged 18 to 59 years and in elderly subjects aged 60 years and above were as follows:
5 Odstotek serozaščite, odstotek serokonverzije in faktor serokonverzije, izmerjeni z enkratno radialno hemolizo (SRH, single radial haemolysis) za protitelesa proti HA po prvem cepljenju odraslih, starih med 18 in 59 let, ter starejših oseb, starih 60 let in več, so bili naslednji:
18 – 59 years
18– 59 let
1st Dose
2. odmerku
2nd Dose 1st Dose
1. odmerku
Seroprotection rate* Seroconversion rate** Seroconversion factor*** * SRH area > 25 mm²
Faktor serokonverzije *** * površina SRH > 25 mm²
55.5% 51.3% 3.7
3, 7
65.4% 57.9% 62.1% 52.4% 4.8 3.6
4, 8 3, 6