natgillin/translations-raw huggingface dataset:
Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Zato mora zdravnik oceniti koristi in možna tveganja uporabe cepiva pri osebah s trombocitopenijo ali kakršnokoli motnjo strjevanja krvi, ki bi bila kontraindikacija za intramuskularno injiciranje, razen če možna korist odtehta tveganje krvavitve.
• Sweating
• znojenje
Allergic reactions may occur following vaccination, in rare cases leading to shock.
Po cepljenju se lahko pojavijo alergijske reakcije, ki v redkih primerih povzročijo šok.
• Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse reactions, unexpected severe adverse reactions, adverse events of special interest (AESI).
• Neželene učinke, ki imajo pri prijavljanju prednost, tj. smrtne in življenje ogrožajoče neželene učinke, nepričakovane hude neželene učinke, neželene učinke posebnega pomena (AESI).
• The Applicant/MAH shall agree with Member States to measures facilitating the identification and traceability of the A/H1N1 pandemic vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
• Predlagatelj/Imetnik dovoljenja za promet se bo z državami članicami dogovoril o ukrepih za lažjo identifikacijo in sledljivost pandemskega cepiva A/H1N1, uporabljenega pri posameznem bolniku, da bi čim bolj zmanjšali napake pri uporabi cepiva ter v pomoč bolnikom in zdravnikom pri poročanju o neželenih učinkih.
The vaccine will be injected into a muscle (usually in the upper arm).
Cepivo vam bodo injicirali v mišico (po navadi na nadlahti).
• Clinical trials
• Klinična preskušanja
If this applies to you then your vaccination will usually be postponed until you are feeling better.
V tem primeru bo zdravnik cepljenje običajno odložil, dokler ne boste ozdraveli.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Znaki alergijske reakcije so lahko srbeč izpuščaj na koži, težko dihanje in otekanje obraza ali jezika.
The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature not exceeding 25°C.
Pripravljeno cepivo lahko shranjujete v hladilniku (2°C - 8°C) ali na sobni temperaturi, ki ne presega 25 °C.
However, in a pandemic situation, it may be appropriate for you to have the vaccine provided that appropriate medical treatment is immediately available in case of an allergic reaction.
Vendar bo v primeru pandemije cepljenje za vas morda priporočljivo, če bo takoj na voljo ustrezna medicinska oprema za primer alergijske reakcije.
>60 years
> 60 let
Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Zdravniki se tega zavedajo in imajo pripravljeno nujno zdravljenje za takšne primere.
Nervous system disorders Febrile convulsions
Bolezni živčevja febrilne konvulzije
• if you have a poor immune response (as for example because of immunosuppressive therapy, e.g. corticosteroid treatments or chemotherapy for cancer),
• če je vaš imunski sistem oslabljen (kot na primer pri imunosupresivni terapiji, npr. kortikosteroidno zdravljenje ali kemoterapija pri raku),
Arepanrix can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Arepanrix takes due account of the officially declared pandemic strain.
Cepivo Arepanrix se lahko sprosti v promet le, če SZO/EU uradno razglasi pandemijo gripe in pod pogojem, da imetnik dovoljenja za promet s cepivom Arepanrix upošteva uradno razglašen pandemski sev.
Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Po cepljenju proti gripi so poročali o lažno pozitivnih rezultatih seroloških testov na osnovi ELISA metode za odkrivanje protiteles proti virusu humane imunske pomanjkljivosti 1 (HIV-1), virusu hepatitisa C in še posebej proti HTLV-1.
In the event of either being observed (including rubber particles from the stopper), discard the vaccine.
Če opazite eno ali drugo (vključno z gumijastimi delci iz zamaška), morate cepivo zavreči.
This medicinal product has been authorised under a so-called “conditional approval” scheme.
Zdravilo je pridobilo tako imenovano »pogojno dovoljenje za promet«.
The Applicant/MAH commits to set a maximum decrease of 20% of HA content for the Drug Substance and to review when data for H1N1 become available.
Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo postavil največ 20 % zmanjšanje vsebnosti HA za zdravilno učinkovino in bo opravil pregled, ko bodo na voljo podatki za H1N1.
If your child receives the vaccine, you should be aware that the side effects may be more intense after the second dose, especially temperature over 38°C.
Če vaš otrok dobi cepivo, morate vedeti, da so lahko neželeni učinki po drugem odmerku izrazitejši; to še zlasti velja za zvišanje telesne temperature nad 38 °C.
If the mixed vaccine is stored in a refrigerator, it should be allowed to reach room temperature before each withdrawal.
Če pripravljeno cepivo shranjujete v hladilniku, morate poskrbeti, da doseže sobno temperaturo preden izvlečete posamezni odmerek.
Immune response to Arepanrix (H1N1) in adults aged 18-60 years:
Imunski odziv na cepivo Arepanrix (H1N1) pri odraslih, starih od 18 do 60 let:
Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno cepivo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Prophylaxis of influenza in an officially declared pandemic situation (see sections 4.2 and 5.1).
KLINIČNI PODATKI 4.1 Terapevtske indikacije Preprečevanje gripe v uradno razglašenih pandemskih razmerah (glejte poglavji 4.2 in 5.1).
The results of this heterologous challenge study indicate 80.7%-100% protection in all adjuvanted candidate vaccines compared to 43% protection with the non adjuvanted vaccine, showing the benefit of AS03 adjuvantation.
Rezultati te heterologne provokacijske študije kažejo od 80,7-odstotno do 100-odstotno zaščito pri vseh kandidatnih cepivih z adjuvansom, v primerjavi s 43-odstotno zaščito pri cepivih brez adjuvansa, kar kaže na korist adjuvansa AS03.
See section 6.5 for the number of doses per vial.
Za število odmerkov v viali glejte poglavje 6.5.
24-35 months4
24-35 mesecev4
The emulsion is a whitish homogeneous liquid.
Emulzija je belkasta homogena tekočina.
Such situation requires rapid notification of safety information that may have the greatest implications for benefit-risk balance in a pandemic.
Takšne okoliščine zahtevajo hitro prijavljanje varnostnih informacij, ki so lahko pri pandemiji izjemno pomembne za razmerje med koristjo in tveganjem.
For a full list of excipients see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
The anti-HA antibody responses 21 days after a first dose were as follows:
Odzivi anti-HA protiteles so bili 21 dni po prvem odmerku naslednji:
After the addition of the adjuvant to the antigen, the mixture should be well shaken.
Potem, ko adjuvans dodate antigenu, morate mešanico dobro pretresti.
The MAH shall submit on a monthly basis a simplified periodic safety update report with the timelines, format and content as defined in the CHMP Recommendations for the Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine (EMEA/359381/2009) and any subsequent update.
Imetnik dovoljenja za promet bo mesečno vlagal poenostavljeno redno posodobljeno poročilo o varnosti s časovnim razporedom, obliko in vsebino, opredeljenimi v Priporočilih za farmakovigilančni načrt CHMP kot del načrta za obvladovanje tveganja, ki mora biti vložen z vlogo za pridobitev dovoljenja za promet s cepivom proti pandemski gripi (EMEA/359381/2009) in morebitnimi poznejšimi posodobitvami.
There are currently no data available on the use of Arepanrix in pregnancy.
Trenutno ni podatkov o uporabi cepiva Arepanrix med nosečnostjo.
If vaccination is considered to be necessary, facilities for resuscitation should be immediately available in case of need.
Če menite, da je cepljenje nujno, mora biti takoj na voljo oprema za oživljanje za nujne primere.
Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant.
Če ste noseči, mislite, da ste noseči, nameravate zanositi, to povejte svojemu zdravniku.
When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease.
Po cepljenju imunski sistem (naravni obrambni sistem telesa) ustvari lastno zaščito (protitelesa) proti bolezni.
As with all vaccines, Arepanrix may not fully protect all persons who are vaccinated.
Kot druga cepiva tudi cepivo Arepanrix morda ne bo popolnoma zaščitilo vseh cepljenih oseb.
anti-HA antibody
anti-HA protitelesa
Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or fetal or neonatal toxicity.
Podatki, pridobljeni pri nosečnicah, ki so bile cepljene z drugačnimi inaktiviranimi sezonskimi cepivi brez adjuvansa, ne nakazujejo na malformacije ali toksične učinke na plod ali novorojenca.
Before the vaccine is mixed:
Pred premešanjem cepiva:
Pharmacovigilance The Applicant/MAH commits to support a Postauthorisation study in immunocompromised subjects (adults with HIV) being conducted by PCIRN (Public Health Agency of Canada - Canadian Institutes of Health Research Influenza Research Network) and provide the final result
Farmakovigilanca Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo podprl postavtorizacijsko študijo pri imunsko oslabelih osebah (odrasli s HIV), ki jo izvaja PCIRN (Public Health Agency of Canada - Canadian Institutes of Health Research Influenza Research Network), in da bo posredoval končne rezultate.
Excipients: the vaccine contains 5 micrograms thiomersal
Pomožne snovi: Cepivo vsebuje 5 mikrogramov tiomersala.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Dokazano je bilo, da je cepivo, pripravljeno za uporabo, pri temperaturi 25°C kemijsko in fizikalno stabilno 24 ur.
Important information about some of the ingredients of Arepanrix This vaccine contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Pomembne informacije o nekaterih sestavinah cepiva Arepanrix To cepivo vsebuje kot konzervans tiomersal, ki lahko povzroči alergijsko reakcijo.
Prospective cohort: initiated 23 Oct 2009; First endpoints available in Feb
Prospektivna kohorta: začetek 23. oktobra 2009, prve končne točke bodo na voljo februarja
The MAH should check regarding the possible confounding layouts with other pandemic vaccine supplied in EU.
Imetnik dovoljenja za promet mora preveriti morebitne možnosti zamenjave načrtov z drugimi pandemskimi cepivi, ki so na trgu v EU.
Persons who have received a seasonal influenza vaccine that does not contain an adjuvant may receive Arepanrix after an interval of at least three weeks.
Osebe, ki so dobile cepivo proti sezonski gripi brez adjuvansa, lahko dobijo cepivo Arepanrix po presledku vsaj treh tednov.
However, if this cannot be avoided, the vaccines should be injected into separate limbs.
Če pa se sočasni uporabi ni mogoče izogniti, je treba cepiva injicirati v različne okončine.
You should discuss with your doctor whether you should receive Arepanrix.
Posvetujte se z zdravnikom, ali morate dobiti cepivo Arepanrix.
From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have also been reported:
Med spremljanjem interpandemskih trivalentnih cepiv po pridobitvi dovoljenja za promet so poročali tudi o naslednjih neželenih učinkih:
4all subjects seronegative prior to vaccination
4Vsi preiskovanci so bili pred cepljenjem seronegativni.
6-9 years
6-9 let
If a second dose is administered there should be an interval of at least three weeks between the first and second dose.
Če je uporabljen drugi odmerek, mora biti med prvim in drugim odmerkom presledek vsaj treh tednov.
Adults including the elderly and children from the age of 10 years onwards: A dose (0.5 ml) of the vaccine will be given
Odrasli, vključno s starejšimi osebami in otroki od 10. leta naprej Dobili boste en odmerek (0,5 ml) cepiva.
Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Cepljenje je treba opraviti z intramuskularnim injiciranjem, po možnosti v deltoidno mišico ali anterolateralni del stegna (odvisno od mišične mase).
21 days after 2nd dose
21. dni po 2. odmerku
If any of these side effects occur, please tell your doctor or nurse immediately.
Če se pojavi kateri od teh neželenih učinkov, morate to nemudoma povedati zdravniku ali medicinski sestri.
Pharmacovigilance The Applicant/MAH commits to support an effectiveness study with Arepanrix ongoing and submit the results one week after being available.
Farmakovigilanca Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo podprl študijo učinkovitosti cepiva Arepanrix, ki že poteka, in bo predložil rezultate en teden potem, ko bodo na voljo.
2.5 ml per vial.
2,5 ml na vialo
Antigen suspension for injection 50 vials: suspension
suspenzija antigena za injiciranje 50 vial: suspenzija
It is recommended that subjects who receive a first dose of Arepanrix should complete the vaccination course with Arepanrix (see section 4.4).
Priporočljivo je, da osebe, ki dobijo prvi odmerek cepiva Arepanrix, cepljenje tudi zaključijo s cepivom Arepanrix (glejte poglavje 4.4).
Immune response to A/Vietnam/1194/2004
Imunski odziv na A/Vietnam/1194/2004
* propagated in eggs ** haemagglutinin
* namnožen v jajcih ** hemaglutinin
Animal studies with Arepanrix do not indicate reproductive toxicity (see section 5.3).
Študije na živalih, opravljene s cepivom Arepanrix, ne kažejo na vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently been given any other vaccine.
Obvestite svojega zdravnika ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Each vial should be shaken and inspected visually for any foreign particulate matter (other than the white sediments described above) and/or abnormal physical appearance.
Vsako posamezno vialo je potrebno pretresti in pregledati, ali morda vsebuje tuje delce (različne od belih sedimentov opisanih zgoraj) in/ali je nenormalnega videza.
• The Applicant/MAH shall agree with Member Sates on the provision of a targeted communication to healthcare professionals which should address the following:
• Predlagatelj/Imetnik dovoljenja za promet se bo z državami članicami dogovoril o zagotavljanju ciljanega obveščanja za zdravnike, ki mora obravnavati naslednje:
This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose, i.e. essentially sodium- and potassium-free.
To cepivo vsebuje manj kot 1 mmol natrija (23 mg) in manj kot 1 mmol kalija (39 mg) na odmerek, kar v bistvu pomeni “brez natrija” in “brez kalija”.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Pri bolnikih z endogeno ali iatrogeno zmanjšanim imunskim odzivom je protitelesni odziv lahko nezadosten.
The Applicant/Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the continuous reassessment of the benefit/risk profile.
Predlagatelj/Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednji program študij, katerih rezultati služijo kot osnova za stalno ponovno oceno razmerja med koristjo in tveganjem.
Immune system disorders Anaphylaxis, allergic reactions
Bolezni imunskega sistema anafilaksa, alergijske reakcije
Pharmacovigilance The Applicant/MAH commits to provide the results of a study in a pregnancy registry conducted with Arepanrix.
Farmakovigilanca Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo predložil rezultate študije registra nosečnosti, izvedene s cepivom Arepanrix.
The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
Klinični pomen titra inhibicije hemaglutinacije (HI) ≥ 1:40 pri otrocih ni znan.
Rare: Neuralgia, transient thrombocytopenia.
Redki: Nevralgija, prehodna trombocitopenija.
The side effects listed below have occurred with Arepanrix (H5N1) in clinical studies in adults, including the elderly.
Neželeni učinki, ki so navedeni spodaj, so se pojavili v kliničnih študijah s cepivom Arepanrix (H5N1) pri odraslih, vključno s starejšimi osebami.
You should not receive Arepanrix:
Cepiva Arepanrix ne smete dobiti:
21 days after 1st dose
21 dni po 1. odmerku
Read the package leaflet before use
Pred uporabo preberite priloženo navodilo.
Immune response to A/Indonesia/5/2005 18-60 years
Imunski odziv proti A/Indonesia/5/2005 18-60 let
04 June 2010
04. junij 2010
05 March 2010
05. marec 2010
The MAH must ensure that the system of pharmacovigilance, as described in version 3.05 (dated September 2009) presented in Module 1.8.1 of the marketing authorisation application, is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3,05 (September 2009), predstavljeni v modulu 1.8.1 vloge za pridobitev dovoljenja za promet, vzpostavljen in da deluje preden začne tržiti zdravilo in ves čas uporabe cepiva.
If you are not sure, talk to your doctor or nurse before having this vaccine.
Če ste negotovi, se pred cepljenjem posvetujte z zdravnikom ali s farmacevtom.
If a second dose of 0.25 ml is given this will be administered at least three weeks after the first dose.
Če je uporabljen drugi odmerek (0,25 ml), ga bo otrok dobil vsaj tri tedne po prvem odmerku.
The frequency of possible side effects listed below is defined using the following convention:
Pogostnost neželenih učinkov, navedenih spodaj, je določena po naslednjem dogovoru:
Immune response to A/Indonesia/5/2005
Imunski odziv proti A/Indonesia/5/2005
The European Medicines Agency (EMEA) will regularly review any new information on the medicine and this package leaflet will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo redno ponovno pregledala vse nove podatke, o tem zdravilu in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GSK Biologicals, Rixensart - Belgium
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM GSK Biologicals, Rixensart - Belgija
Skin and subcutaneous tissue disorders Angioedema, generalised skin reactions, urticaria
Bolezni kože in podkožja angioedem, generalizirane kožne reakcije, urtikarija
• Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems)
• Vaskulitis (vnetje žil, ki lahko povzroči izpuščaje na koži, bolečine v sklepih in težave z ledvicami).
There are no safety, immunogenicity or efficacy data to support interchangeability of Arepanrix with other H1N1 pandemic vaccines.
Ni podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi potrjevali zamenljivost cepiva Arepanrix z drugimi pandemskimi cepivi proti H1N1.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 (dated January 2010) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, sprejetem v različici 4 (januar 2010) načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah načrta za obladovanje tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
3-5 years
3 do 5 let
What Arepanrix is and what it is used for Before you receive Arepanrix How Arepanrix is given Possible side effects
Kaj je cepivo Arepanrix in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili cepivo Arepanrix Kako uporabljati cepivo Arepanrix Možni neželeni učinki
In the event of other variation being observed, discard the vaccine.
Če opazite kakšno drugo spremembo, morate cepivo zavreči.
The MAH should provide an inventory of all valuable database ready to be use to promptly investigate issues affecting the benefit-risk balance of the vaccine.
Imetnik dovoljenja za promet mora posredovati seznam vseh pomembnih podatkovnih baz, pripravljenih za uporabo za takojšnjo proučitev vprašanj, ki zadevajo razmerje koristi in tveganj cepiva.
• Pain in the back or neck, stiffness in the muscles, muscle spasms, pain in extremity such as leg or hand
• bolečina v hrbtu ali vratu, mišična okorelost, mišični krči, bolečina v rokah ali nogah.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a syringe and by adding it to the vial containing the antigen.
Cepivo zmešate tako, da z injekcijsko brizgo izvlečete celotno vsebino viale adjuvansa in jo dodate v vialo z antigenom.
Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a syringe for injection and administered intramuscularly.
Vsak odmerek cepiva z 0,5 ml (polni odmerek) ali z 0,25 ml (polovični odmerek) izvlecite v injekcijsko brizgo in injicirajte intramuskularno.
One pack of Arepanrix consists of:
Eno pakiranje cepiva Arepanrix vsebuje:
Arepanrix should under no circumstances be administered intravascularly.
Cepiva Arepanrix se v nobenem primeru ne sme injicirati v žilo.
Gastro-intestinal symptoms and shivering were at a higher rate in the children 10-17 years of age.
Prebavni simptomi in drgetanje so bili pogostejši pri otrocih, starih od 10 do 17 let.
Adults aged 18-60 years:
Odrasli, stari od 18 do 60 let:
The Applicant/MAH commits to provide abridged report for the following study performed in children
Predlagatelj/imetnik dovoljenja za promet se zavezuje, da bo predložil skrajšano poročilo o naslednji študiji, izvedeni pri otrocih:
Conversely the combination of a range of doses of H5N1 antigen with AS03 adjuvant was able to protect against mortality and to reduce lung virus loads and viral shedding after intra-tracheal challenge with a homologous wild type H5N1 virus.
Nasprotno pa je kombinacija različnih odmerkov antigena H5N1 z adjuvansom AS03 bele dihurje zaščitila pred poginom in zmanjšala virusno breme v pljučih ter izločanje virusa po intratrahealni provokaciji s homolognim divjim tipom virusa H5N1.
The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically with A/Indonesia/05/05 (H5N1) using ferret challenge models.
Sposobnost za indukcijo zaščite proti homolognim in heterolognim cepilnim sevom so ocenili predklinično z A/Indonesia/05/05 (H5N1) s provokacijskim modelom pri belem dihurju.