natgillin/translations-raw huggingface dataset:
The study showed that Focetria produced an antibody response that satisfies these criteria.
Raziskava je pokazala, da zdravilo Focetria izzove odziv protiteles, ki zadovolji to merilo.
Twenty-one days after the second injection, 86% of the people receiving the vaccine with 7.5 micrograms haemagglutinin had levels of antibodies that would protect them against H5N1.
Enaindvajset dni po drugem injiciranju je imelo 86% ljudi, ki so prejeli cepivo s 7, 5 mikrogrami hemaglutinina, tako koncentracijo protiteles, ki bi jih lahko zaščitila proti H5N1.
The figure was 85% in the patients who received the 15-micrograms dose.
Pri bolnikih, ki so prejeli 15- mikrogramski odmerek, je bila ta številka 85%.
The most common side effects with Focetria (seen in between 1 and 10 people in 100) are headache, sweating, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (redness, swelling, hardening, bruising, pain), fever, malaise (feeling unwell), fatigue (tiredness) and shivering.
Najpogostejši neželeni učinki zdravila Focetria (opaženi pri 1 do 10 od 100 oseb) so bili glavobol, znojenje, artralgija (bolečine v sklepih), mialgija (bolečine v mišicah), reakcije na mestu injiciranja (rdečina, otekanje, otrdelost, modrice, bolečine), vročina, občutek slabosti (slabo počutje), utrujenost in drhtavica.
For the full list of all side effects reported with Focetria, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri cepivu Focetria, glejte Navodilo za uporabo.
Focetria should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace levels in the vaccine, such as eggs, chicken protein, kanamycin or neomycin sulphate (two antibiotics), formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80.
Cepiva Focetria se ne sme dajati osebam, ki so imeli v preteklosti anafilaktično reakcijo (hudo alergijsko reakcijo) na katero koli izmed sestavin cepiva ali na katero koli od snovi, ki se v sledovih nahajajo v cepivu, kot na primer na jajca, piščančje beljakovine, kanamicin ali neomicinsulfat (dva antibiotika), formaldehid, cetiltrimetilamonijev bromid (CTAB) in polisorbat 80.
If a pandemic has started, however, it may be appropriate to give the vaccine to these patients, as long as facilities for resuscitation are available.
Vendar pa bo v pandemičnih razmerah cepljenje takih bolnikov morda vseeno upravičeno, če bo na razpolago oprema za oživljanje.
The Committee for Medicinal Products for Human Use (CHMP) decided that Focetria’ 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 Focetria večje od z njim povezanih tveganj pri preprečevanju gripe v uradno razglašenih pandemičnih razmerah.
The committee recommended that Focetria be given marketing authorisation.
Odbor je zato priporočil odobritev dovoljenja za promet z zdravilom Focetria.
Focetria has been authorised under “ Exceptional Circumstances”.
Zdravilo Focetria 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 tega, ker sev virusa gripe, ki utegne povzročiti pandemijo, ni znan, ni bilo mogoče pridobiti celovitih 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 nove informacije, ki bodo morda postale dostopne, in po potrebi posodobila ta povzetek.
What information is still awaited for Focetria?
Katere informacije o zdravilu Focetria še pričakujemo?
If a pandemic is declared, the company that makes Focetria will include the flu strain responsible in the vaccine.
V primeru razglasitve pandemije, bo podjetje, ki izdeluje zdravilo Focetria, v cepivo vključilo 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.
Tedaj bodo zbrali informacije o varnosti in učinkovitosti končnega pandemičnega cepiva in jih posredovali v oceno CHMP.
Which measures are being taken to ensure the safe use of Focetria?
Kateri ukrepi se izvajajo za zagotavljanje varne uporabe zdravila Focetria?
If Focetria 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 Focetria uporabljalo med pandemijo, bo podjetje, ki ga izdeluje, zbralo informacije o varnosti cepiva med njegovo uporabo.
This will include information on its side effects and its safety in children, 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 otrocih, nosečnicah, resno bolnih bolnikih in ljudeh, ki imajo težave z imunskim sistemom.
Other information about Focetria:
Druge informacije o cepivu Focetria:
The European Commission granted a marketing authorisation valid throughout the European Union for Focetria to Novartis Vaccines and Diagnostics S. r. l. on 2 May 2007.
Stran 2/ 3 ©EMEA 2007 Evropska komisija je dovoljenje za promet z zdravilom Focetria, veljavno po vsej Evropski uniji, odobrila družbi Novartis Vaccines and Diagnostics S. r. l. dne 2. maja 2007.
The full EPAR for Focetria can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Focetria je na voljo tukaj.
©EMEA 2007
Povzetek je bil nazadnje posodobljen 05- 2007.
2/ 2
Stran 3/ 3 ©EMEA 2007
0.5 ml (1 dose = 0.5ml)
0, 5 ml (1 odmerek = 0, 5 ml)
5.0 ml (1 dose = 0.5 ml)
5, 0 ml (1 odmerek = 0, 5 ml)
10 vials (multidose:
10 vial (večkratni odmerek:
Focetria suspension for injection in pre-filled syringe Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted)
Cepivo proti pandemični gripi (površinski antigen, inaktiviran, z adjuvansom)
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Površinski antigeni (hemaglutinin in nevraminidaza) * naslednjega seva virusa influence:
7.5 micrograms** per 0.5 ml dose
7, 5 mikrogramov ** na odmerek 0, 5 ml
* propagated in eggs ** expressed in microgram haemagglutinin.
* razmnoženi v jajcih ** izraženo v mikrogramih hemaglutinina.
polysorbate 80 sorbitan trioleate
Adjuvans MF59C. 1 vsebuje: skvalen polisorbat 80 sorbitantrioleat
1.175 milligrams 1.175 milligrams
9, 75 miligramov 1, 175 miligramov 1, 175 miligramov
This vaccine complies with the WHO recommendations and EU
Cepivo je skladno s priporočili SZO in odločbo EU za pandemijo.
Milky-white liquid.
Mlečno bela tekočina.
Pandemic influenza vaccine should be used in accordance with Official Guidance (see sections 4.2 and 5.1).
Cepivo proti pandemični gripi je treba uporabljati v skladu z Uradnimi Smernicami (glejte poglavji 4. 2 in 5. 1).
Focetria has been evaluated in adults aged 18-60 years and elderly over 60 years following a 0, 21 day schedule.
Zdravilo Focetria je bilo ocenjeno pri odraslih, starih od 18 do 60 let, in starejših bolnikih, starih več kot 60 let, po razporedu cepljenja prvi in 21. dan.
No data are available in subjects below 18 years or in children.
Pri osebah, mlajših od 18 let, in otrocih ni podatkov.
Therefore health care providers need to assess the benefits and potential risks of administering the vaccine in that population.
Zdravniki morajo zato oceniti koristi in morebitna tveganja uporabe cepiva pri tej populaciji.
History of an anaphylactic (i. e. life-threatening) reaction to any of the constituents or trace residues of eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB) of this vaccine.
Anafilatične (tj. smrtno nevarne) reakcije na katero koli sestavino cepiva ali ostanke jajc v sledovih, piščančje beljakovine, kanamicin in neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid (CTAB) v anamnezi.
See section 4.4. for Special warnings and special precautions for use.
Za posebna opozorila in previdnostne ukrepe glejte poglavje 4. 4.
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 and to eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB).
Pri uporabi tega cepiva pri osebah z znano preobčutljivostjo (razen anafilaktičnih reakcij) na zdravilno učinkovino, katero koli pomožno snov in na jajca, piščančje beljakovine, kanamicin in neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid (CTAB) je treba biti previden.
The vaccine should under no circumstances be administered intravascularly or subcutaneously.
Cepiva se v nobenem primeru ne sme dajati intravaskularno ali subkutano.
A protective response may not be induced in all vaccines (see section 5.1).
Zaščitni odziv morda ne bo sprožen pri vseh cepivih (glejte poglavje 5. 1).
Focetria should not be given at the same time as other vaccines.
Cepiva Focetria se ne sme dajati sočasno z drugimi cepivi.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed.
Po cepljenju proti gripi so opazili lažne pozitivne rezultate pri seroloških preizkusih z metodo ELISA za odkrivanje protiteles proti virusu HIV- 1, virusu hepatitisa C in zlasti proti virusu HTLV 1.
The Western Blot technique disproves the results.
Te rezultate je mogoče ovreči z analizo Western blot.
The transient false positive reactions could be due to the IgM response by the vaccine.
Prehodni lažno pozitivni rezultati so lahko posledica odziva protiteles IgM na cepivo.
No data have been generated with Focetria in pregnant women.
Podatkov o uporabi zdravila Focetria pri nosečnicah ni.
Therefore health care providers need to assess the benefits and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.
Zato morajo zdravniki oceniti koristi in morebitna tveganja uporabe cepiva pri nosečnicah in pri tem upoštevati uradna priporočila.
Data from vaccinations with seasonal interpandemic inactivated trivalent vaccines in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine.
Podatki iz cepljenj s sezonskimi interpandemičnimi inaktiviranimi trivalentnimi cepivi pri nosečnicah ne kažejo na neželene učinke na plod ali mater, ki bi jih lahko pripisali cepivu.
4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroj
Focetria is unlikely to produce any effect on the ability to drive and use machines.
Ni verjetno, da bi imelo cepivo Focetria vpliv na sposobnost vožnje in upravljanja s stroji.
• Clinical trials
• Kliniča preskušanja
In clinical trials with different formulations (H5N3, H9N2 and H5N1) 542 subjects were exposed to thecandidate vaccine.
V kliničnih preskušanjih z različnimi formulacijami (H5N3, H9N2 in H5N1) je bilo testnemu cepivu izpostavljenih 542 oseb.
Of theses subjects, 464 subjects received the mock-up vaccine (A/ H5N1).
Med njimi je skupaj 464 oseb prejelo demonstracijsko cepivo (A/ H5N1).
From the clinical trials with the pandemic vaccine, most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
V kliničnih preskušanjih s cepivom proti pandemični gripi je bila večina reakcij blagih, kratkotrajnih in kakovostno podobnih reakcijam, ki jih povzročajo običajna cepiva proti sezonski gripi.
3 Adverse reactions from clinical trials with the mock-up vaccine are listed below (see section 5.1 for more information on mock-up vaccines).
3 Neželeni učinki v kliničnih preskušanjih z demonstracijskim cepivom so navedene spodaj (za dodatne informacije o demonstracijskih cepivih glejte poglavje 5. 1).
Nervous system disorders Common (> 1/ 100, < 1/ 10): headache
Bolezni živčevja Pogosti (> 1/ 100, < 1/ 10): glavobol
Skin and subcutaneous tissue disorders Common (> 1/ 100, < 1/ 10): sweating
Bolezni kože in podkožja Pogosti (> 1/ 100, < 1/ 10): potenje
Muscoskeletal, connective tissue and bone disorders Common (> 1/ 100, < 1/ 10): arthralgia and myalgia
Bolezni mišično- skeletnega sistema in vezivnega tkiva Pogosti (> 1/ 100, < 1/ 10): artralgija in mialgija
General disorders and administration site conditions Common (> 1/ 100, < 1/ 10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering
Splošne težave in spremembe na mestu aplikacije Pogosti (> 1/ 100, < 1/ 10): rdečica na mestu injiciranja, otekanje na mestu injiciranja, induracija na mestu injiciranja, ekhimoza na mestu injiciranja in bolečina na mestu injiciranja, zvišana telesna temperatura, slabotnost, utrujenost in tresenje
• Post-marketing surveillance
• Postmarketinški nadzor
From Post-marketing surveillance with adjuvanted interpandemic trivalent vaccines with the similar composition of Focetria (surface antigen, inactivated, adjuvanted with MF59C.1), the following adverse events have been reported:
V postmarketinškem nadzoru interpandemičnih trivalentnih cepiv z adjuvansom, katerih sestava je bila podobna cepivu Focetria (površinski antigen, inaktivirano cepivo, z adjuvansom MF59C. 1), so poročali o naslednjih neželenih učinkih:
Uncommon (> 1/ 1,000, < 1/ 100):
Občasni (> 1/ 1. 000, < 1/ 100):
Generalised skin reactions including pruritus, urticaria or non-specific rash.
Generalizirane kožne reakcije, vključno s pruritusom, urtikarijo ali neznačilnim izpuščajem.
Rare (> 1/ 10,000, < 1/ 1,000):
Redki (> 1/ 10. 000, < 1/ 1. 000):
Neuralgia, paraesthesia, convulsions, transient thrombocytopenia.
Nevralgija, parestezija, konvulzije, prehodna trombocitopenija.
Allergic reactions, in rare cases leading to shock, have been reported.
Poročali so o alergijskih reakcijah, ki so v redkih primerih povzročile šok.
Influenza vaccine, ATC Code:
Cepiva proti gripi, oznaka ATC:
This section describes the clinical experience with the mock-up vaccines following a two-dose administration.
V tem poglavju so opisane klinične izkušnje z demonstracijskimi cepivi po uporabi dveh odmerkov.
These antigens can be considered as ‘ novel’ antigens and simulate a situation where the 4 target population for vaccination is immunologically naïve.
Ti antigeni delujejo kot "novi" antigeni in posnemajo stanje, pri katerem ciljna populacija še ni bila cepljena.
A clinical trial was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 486 healthy adult volunteers.
Pri 486 zdravih odraslih prostovoljcih so opravili klinično preskušanje s cepivom proti sevu H5N1, kombiniranim z adjuvansom MF59C. 1.
Two doses of vaccine containing H5N1 (A/ Vietnam/ 1194/ 2004) at 2 different dosages (7.5 and 15 µg hemagglutinin [HA]/ dose) with MF59C.1 adjuvant were administered three weeks apart.
Dva odmerka cepiva s sevom H5N1 (A/ Vietnam/ 1194/ 2004) z dodanim adjuvansom MF59C. 1 so uporabili v presledku treh tednov pri dveh različnih odmerkih (7, 5 in 15 µg hemaglutinina [HA] / odmerek).
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody in the adults measured by SRH were as follows:
Stopnja serološke zaščite *, stopnja serološke konverzije * in faktor serološke konverzije, izmerjeni s SRH za protitelesa proti HA, so bili pri odraslih naslednji:
anti-HA antibody
protitelesa proti HA
22 days after 1st dose
22 dni po prvem odmerku
Seroprotection rate Seroconversion rate Seroconversion factor * measured by SRH assay ≥ 25 mm ** geometric mean ratios of SRH
Stopnja serološke zaščite Stopnja serološke konverzije Faktor serološke konverzije ** * Izmerjeno z metodo SRH ≥ 25 mm.
41% (95% CI:
41% (95% IZ:
33-49) 39% (95% CI:
33– 49) 39% (95% IZ:
86% (95% CI:
86% (95% IZ:
79-91) 85% (95% CI:
79– 91) 85% (95% IZ:
The seroprotection rate*, seroconversion rate* and the seroconversion factor ** for anti-HA antibody in subjects aged over 60 measured by SRH were as follows:
Stopnja serološke zaščite *, stopnja serološke konverzije * in faktor serološke konverzije ** izmerjeni s SRH za protitelesa proti HA, so bili pri starejših od 60 let naslednji:
Seroprotection rate Seroconversion rate Seroconversion factor * measured by SRH assay ≥ 25 mm ** geometric mean ratios of SRH
Stopnja serološke zaščite Stopnja serološke konverzije Faktor serološke konverzije ** * Izmerjeno s preiskavo SRH ≥ 25 mm.
53% (95% CI:
53% (95% IZ:
42-64) 45% (95% CI:
42– 64) 45% (95% IZ:
81% (95% CI:
% (95% IZ:
71-89) 71% (95% CI:
71– 89)% (95% IZ:
The persistence of antibodies for the mock-up vaccines varies.
Persistenca protiteles se je pri demonstracijskem cepivu razlikovala.
With the interpandemic trivalent vaccines it is usually 6-12 months, but for this vaccine no data are available yet with the H5N1 strain.
Pri interpandemičnih trivalentnih cepivih je ta po navadi 6 do 12 mesecev, pri tem cepivu pa podatki za sev H5N1 še niso na voljo.
• Supportive Studies
• Podporne študije
Two doses of vaccine with H5N3 (A/ Duck/ Singapore/ 97) strain at 3 different dosages (7.5, 15 and 30 µg HA/ dose) were administered three weeks apart.
Dva odmerka cepiva s sevom H5N3 (A/ Duck/ Singapore/ 97) so uporabili v presledku treh tednov pri treh različnih odmerkih (7, 5; 15 in 30 µg HA/ odmerek).
Serologic responses obtained with the SRH assay showed that 100% of subjects achieved seroprotection and 100% seroconverted after two 7.5 μ g injections.
Serološki odziv, pridobljen z metodo SRH, je pokazal, da je do serološke zaščite prišlo pri 100% oseb in da se je po dveh 7, 5- mikrogramskih injekcijah pri 100% pojavila serološka konverzija.
Two doses of vaccine containing H9N2 (A/ chicken/ Hong Kong/ G9/ 97) strain at 4 different dosages (3.75, 7.5, 15 and 30 µg HA/ dose), were administered four weeks apart.
V presledku 4 tednov so pri 4 različnih odmerkih (3, 75; 7, 5; 15 in 30 μg HA/ odmerek) uporabili dva odmerka cepiva, ki je vsebovalo sev H9N2 (A/ Chicken/ Hong Kong/ G9/ 97).
Serologic responses obtained with the Hemagglutination Inhibition (HI) assay showed that 92% of subjects achieved seroprotection and 75% seroconverted after two 7.5 μ g injections.
Serološki odziv, pridobljen z metodo zaviranja hemaglutinacije (Hemagglutination Inhibition – HI), je pokazal, da je do serološke zaščite prišlo pri 92% oseb in da se je po dveh 7, 5- mikrogramskih injekcijah pri 75% pojavila serološka konverzija.
Focetria has been authorised under “ Exceptional Circumstances”.
Zdravilo Focetria je pridobilo dovoljenje za promet v "izjemnih okoliščinah".
5 Not applicable.
5 Evropska agencija za zdravila (EMEA) bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo, in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
5.3 Preclinical safety data
Navedba smiselno ni potrebna.
Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Sodium citrate, Citric acid, Water for injections.
Natrijev klorid Kalijev klorid Kalijev dihidrogenfosfat Dinatrijev fosfat dihidrat Magnezijev klorid heksahidrat Kalcijev klorid dihidrat Natrijev citrat Citronska kislina Voda za injekcije.
0.5 ml in pre-filled syringe (type I glass) with plunger-stopper (bromo-butyl rubber).
0, 5 ml v napolnjeni injekcijski brizgi (steklo vrste I) z zamaškom na batu (bromobutilna guma).
Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, Italy.
Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, Italija.
Focetria suspension for injection Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted)
Cepivo proti pandemični gripi (površinski antigen, inaktiviran, z adjuvansom)
8 4.3 Contraindications
8 4. 3 Kontraindikacije
9 Adverse reactions from clinical trials with the mock-up vaccine are listed below (see section 5.1 for more information on mock-up vaccines).
9 Neželeni učinki v kliničnih preskušanjih z demonstracijskim cepivom so navedene spodaj (za dodatne informacije o demonstracijskih cepivih glejte poglavje 5. 1).
These antigens can be considered as ‘ novel’ antigens and simulate a situation where the 10 target population for vaccination is immunologically naïve.
Ti antigeni delujejo kot "novi" antigeni in posnemajo stanje, pri katerem ciljna populacija še ni bila cepljena.
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody in subjects aged over 60 measured by SRH were as follows:
Stopnja serološke zaščite *, stopnja serološke konverzije * in faktor serološke konverzije ** izmerjeni s SRH za protitelesa proti HA, so bili pri starejših od 60 let naslednji:
11 Not applicable.
11 Evropska agencija za zdravila (EMEA) bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo, in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
0.5 ml in single-dose vial (type I glass) with stopper (halo-butyl rubber).
0, 5 ml v viali z enkratnim odmerkom (steklo vrste I) z zamaškom (halobutilna guma).
Focetria suspension for injection in multidose container Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted)
Cepivo proti pandemični gripi (površinski antigen, inaktiviran, z adjuvansom)
7.5 micrograms ** per 0.5 ml dose
7, 5 mikrogramov ** na odmerek 0, 5 ml
Adjuvant MF59C.1 containing: squalene
Adjuvans MF59C. 1 vsebuje: skvalen polisorbat 80 sorbitantrioleat
polysorbate 80 sorbitan trioleate Excipients:
9, 75 miligramov 1, 175 miligramov 1, 175 miligramov
1.175 milligrams 1.175 milligrams
Pomožne snovi:
0.05 milligrams
0, 05 miligramov
See section 6.5 for the number of doses per vial.
Glejte poglavje 6. 5 za število odmerkov v viali.
14 For pregnant women, see section 4.6.
14 Za nosečnice glejte poglavje 4. 6.
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, to thiomersal and to eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB).
Pri uporabi tega cepiva pri osebah z znano preobčutljivostjo (razen anafilaktičnih reakcij) na zdravilno učinkovino, katero koli pomožno snov, na tiomersal in na jajca, piščančje beljakovine, kanamicin in neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid (CTAB) je treba biti previden.
4.8 Undesirable effects
• Kliniča preskušanja
• Clinical trials In clinical trials with different formulations (H5N3, H9N2 and H5N1) 542 subjects were exposed to thecandidate vaccine.
V kliničnih preskušanjih z različnimi formulacijami (H5N3, H9N2 in H5N1) je bilo testnemu cepivu izpostavljenih 542 oseb.
It is widely
Na splošno
15 accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional, nonadjuvanted influenza vaccines.
15 velja, da je učinek adjuvansa, ki poveča imunogenost cepiva, povezan z nekoliko večjo pogostnostjo lokalnih reakcij (večinoma blagih bolečin) v primerjavi z običajnimi cepivi proti gripi brez adjuvansov.
Adverse reactions from clinical trials with the mock-up vaccine are listed below (see section 5.1 for more information on mock-up vaccines).
Neželeni učinki v kliničnih preskušanjih z demonstracijskim cepivom so navedene spodaj (za dodatne informacije o demonstracijskih cepivih glejte poglavje 5. 1).
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
To zdravilo vsebuje tiomersal (živosrebrova organska spojina) kot konzervans, zato lahko pride do senzibilizacije (glejte poglavje 4. 4).
5.1 Pharmacodynamic properties 16 Pharmacotherapeutic group:
5. 1 Farmakodinamične lastnosti