natgillin/translations-raw huggingface dataset:
There is limited experience in the elderly
Za starejše osebe so izkušnje omejene.
Reactogenicity after a third dose, administered 12 months following the first dose, was higher than after both first and second dose.
Reaktogenost po tretjem odmerku, danem 12 mesecev po prvem odmerku, je bila višja kot po obeh, prvem in drugem odmerku.
Viral shedding and viral titers in lungs were also reduced, suggesting that vaccination may reduce the risk of viral transmission.
Zmanjšali so se tudi razmnoţevanje virusa in titri virusa v pljučih, kar kaţe, da lahko cepivo zmanjša tveganje prenosa virusa.
Adults and elderly (18 years of age and above):
Odrasli in starejši bolniki (stari več kot 18 let):
A protective immune response may not be elicited in all vaccinees (see section 5.1).
Zaščitni imunski odziv morda ne bo doseţen pri vseh cepljenih osebah (glejte poglavje
If you have any further questions on the use of this medicinal product, ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom ali s farmacevtom.
If this applies to you then your vaccination will usually be postponed until you are feeling better.
V tem primeru bo zdravnik cepljenje verjetno preloţil na kasneje, ko se boste počutili bolje.
Compared to the antibody levels obtained at day 43 after completion of primary vaccination schedules, antibody levels at day 202 were reduced by 1/5 to 1/2 from their prior levels.
V primerjavi z ravnmi protiteles, pridobljenimi 43. dan po zaključku primarnega reţima cepljenja, so bile ravni protiteles 202. dan zmanjšane za 1/5 do 1/2 glede na predhodne ravni.
Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems), and exudative erythema multiforme (type of allergic skin reaction that occurs in response to medications, infections, or illness).
Vaskulitis (vnetje krvnih ţil, ki lahko povzroči koţne izpuščaje, bolečine v sklepih in teţave z ledvicami), eksudativni multiformni eritem (vrsta alergijske koţne reakcije, ki se pojavi v odziv na zdravila, okuţbe ali bolezen).
87% of animals challenged with virus heterologous to the vaccine strain after 2 doses of vaccine were protected, and a single dose of heterologous vaccine protected 56% of the animals.
87 % ţivali, provociranih z virusom heterolognim na sev, je bilo zaščitenih po 2 odmerkih cepiva in 56 % ţivali, ki so prejele en odmerek heterolognega cepiva.
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 laţno pozitivnih rezultatih seroloških testov z metodo ELISA za odkrivanje protiteles proti virusu humane imunske pomanjkljivosti 1 (HIV-1), virusu hepatitis C in zlasti proti virusu HTLV-1.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 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 izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 3 načrta za obvladovanje tveganja (RMP), predloţenem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
Vaccination protected animals from lethal challenge even when HI antibody titers were low or undetectable.
Cepljenje je zaščitilo ţivali pred letalno provokacijo tudi, ko so bili titri protitelesa HI nizki ali nedoločljivi.
Low blood platelet count which can result in bleeding or bruising.
Zmanjšano število trombocitov v krvi, kar lahko povzroči krvavitve ali modrice.
Two doses of vaccine protected 92% of animals, and a single dose of vaccine protected 50% of animals against the A/Indonesia/5/05 virus.
Dva odmerka cepiva sta zaščitila 92 % ţivali, medtem ko je en odmerek cepiva pred virusom A/Indonesia/5/05 zaščitil 50 % ţivali.
When a person is given the vaccine, the immune system (the body's natural defense system) will produce its own protection (antibodies) against the disease.
Imunski sistem (naravni obrambni sistem telesa) osebe, ki dobi cepivo, začne izločati lastno zaščito (protitelesa) proti bolezni.
Persistence of antibodies after primary vaccination in this population was assessed by HI, SRH, and MN assays.
Obstojnost protiteles po primarnem cepljenju v tej populaciji je bila ocenjena s testi HI, SRH in MN.
PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Influenza vaccine ATC Code J07BB02.
Farmakoterapevtska skupina: Cepivo proti gripi, oznaka ATC: J07BB02.
Data in children and adolescents suggest a slight decrease in side effects after the second dose of the vaccine, with no increase in rates of fever.
Podatki za otroke in mladostnike kaţejo rahlo zniţanje reaktogenosti po drugem odmerku cepiva brez zvišanja stopnje zvišane telesne temperature.
The vaccine should be allowed to reach room temperature before use.
Pred uporabo počakajte, da doseţe cepivo sobno temperaturo.
In a similar study, intranasal challenge was delayed until approximately 4 months after the second dose of vaccine containing either 3.75 or 7.5 micrograms of antigen was administered.
V podobni študiji so z intranazalno provokacijo počakali pribliţno 4 mesece po drugem odmerku cepiva, ki je vsebovalo bodisi 3,75 ali 7,5 mikrograma antigena.
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 med drugim koţni osip, zasoplost in oteklost obraza ali jezika.
In toddlers erythema and tenderness were the most commonly reported solicited local reactions; irritability and unusual crying were the most commonly reported solicited systemic reactions.
Pri malčkih so bile najpogostejše pričakovane lokalne reakcije eritem in napetost; razdraţljivost in neobičajen jok sta bili najpogosteje poročani pričakovani sistemski reakciji.
Loc. Bellaria - 53018 Rosia Sovicille (SI), Italy.
Loc. Bellaria - 53018 Rosia Sovicille (SI), Italija
Allergic reactions possibly with shortness of breath, wheezing, swelling of the throat, or leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock.
Alergijske reakcije, ki so lahko vključevale kratko sapo, sopenje, oteklost grla ali alergijske reakcije, ki povzročijo nevarno zniţanje krvnega tlaka, ki lahko, če stanje ni zdravljeno, povzročijo šok.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000)
Pogostnost spodaj naštetih moţnih neţelenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti (pojavijo se pri več kot 1 od 10 bolnikov) pogosti (pojavijo se pri 1 do 10 od 100 bolnikov) občasni (pojavijo se pri 1 do 10 od 1.000 bolnikov) redki (pojavijo se pri 1 do 10 od 10.000 bolnikov) zelo redki (pojavijo se pri manj kot 1 od 10.000 bolnikov)
In this study 100% of animals were protected against homologous challenge, and 81% of animals were protected against heterologous challenge.
V tej študiji je bilo pred homologno provokacijo zaščitenih 100 % ţivali in pred heterologno provokacijo 81 % ţivali.
Adverse reactions from clinical trials in adults (18 years old and above).
Neţeleni učinki iz kliničnih preskušanj pri odraslih bolnikih (starih 18 let ali več).
In this trial no vaccine related SAEs were observed.
V tem preskušanju niso opazili neţelenih učinkov, povezanih s cepivom.
Day 43 to Day 1 % SC (95% CI)
43. dan do 1. dan % SK (95-odstotni IZ)
“Possible side effects” may affect the ability to drive or use machines.
Moţni neţeleni učinki“, lahko vplivajo na sposobnost voţnje in upravljanja s stroji.
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 neţeleni učinki, ki so jih v skupini otrok, starih med 6 in 35 meseci opazili zelo pogosto, so bili pordelost na mestu injiciranja, mišične bolečine, razdraţljivost in neobičajen jok.
Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are pregnant or breast-feeding.
Vaš zdravnik bo presodil razmerje med koristmi in moţnimi tveganji cepljenja, če ste noseči ali dojite.
In children and adolescents pain was the most frequently reported solicited local reaction, and fatigue and headache were the most commonly reported solicited systemic reactions.
Pri otrocih in mladostnikih je bila najpogosteje poročana lokalna reakcija bolečina, najpogosteje poročani pričakovani sistemski reakciji pa sta bili utrujenost in glavobol.
Use in children There is limited experience in children between 6 months and 17 years of age.
Uporaba pri otrocih Pri otrocih, starih med 6 meseci in 17 leti, so izkušnje omejene.
Across all ages, low percentages of subjects reported fever.
V vseh starostnih skupinah je bio odstotek poročane povišane telesne temperature nizek.
Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.
Alergijske reakcije, anafilaksa vključno z dispnejo, bronhospazem, edem grla, ki v redkih primerih povzroči šok
Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), and a type of paralysis known as Guillain-Barré Syndrome.
Nevrološke motnje kot so encefalomielitis (vnetje osrednjega ţivčevja) in vrsta paralize, znana kot Guillain-Barré sindrom.
No increase in reactions was reported when a booster dose is administered 6 months-18 months later after the initial dosing series.
Niso poročali o povečanju števila neţelenih učinkov ob dajanju obnovitvenega odmerka 6 mesecev-18 mesecev po seriji začetnih odmerkov.
Vaccination protected animals from lethal challenge with virus homologous and heterologous to the vaccine.
Cepljenje je ţivali zaščitilo pred letalno provokacijo z virusom, homolognim in heterolognim na cepivo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 29 November 2010
29. november 2010
The vaccine contains per 0.5ml 9.75 mg squalene, 1.175 mg polysorbate 80 and 1.175 mg
Cepivo vsebuje na 0,5 ml 9,75 mg skvalena, 1,175 mg polisorbata 80 in 1,175 mg sorbitantrioleata.
1 x single dose of 0.5 ml pre-filled syringe 10 x single dose of 0.5 ml pre-filled syringes
1 x enojni odmerek 0,5 ml v napolnjeni injekcijski brizgi 10 x enojni odmerek 0,5 ml v napolnjenih injekcijskih brizgah
This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/Vietnam/1194/2004 (H5N1)-like strain (see section 5.1).
Ta indikacija temelji na podatkih o imunogenosti za zdrave osebe, starejše od 18 let, po cepljenju z dvema odmerkoma cepiva, ki vsebuje sevu A/Vietnam/1194/2004 (H5N1) podoben sev (glejte poglavje 5.1).
Preliminary data from spontaneously reported events and ongoing post-marketing studies (pregnancy registry and prospective interventional study) do not suggest direct or indirect harmful effects on influenza vaccines adjuvanted with MF59 with respect to pregnancy, fertility, embryonic/foetal development, parturition, or post natal development.
Predhodni podatki iz spontano poročanih dogodkov iz in potekajočih študijah, ki potekajo po začetku trţenja (register nosečnosti in prospektivne intervencijske študije) ne kaţejo na neposredne ali posredne škodljive vplive na cepiva proti gripi z adjuvansom MF59 glede na nosečnost, plodnost, razvoj embria/fetusa, porod ali razvoj po rojstvu.
Some heterologous immune response against A/H5N1/turkey/Turkey/05 (NIBRG23; clade2.2) and A/H5N1/Indonesia (clade 2.1) was detectable both after the second and third vaccinations, indicating cross-reactivity of the clade 1 vaccine against clade 2 strains.
Nekaj heterolognega imunskega odziva proti sevu A/H5N1/turkey/Turkey/05 (NIBRG23; gruča 2.2) in A/H5N1/Indonesia (gruča 2.1) so zaznali tako po drugem kot po tretjem cepljenju, kar kaĎe na kriţno reaktivnost cepiva gruče 1 proti sevom gruče 2.
A slight increase in reactions in adults was reported when a booster dose is administered 18 months after the initial dosing series.
Poročali so o rahlem povečanju reakcij pri odraslih, ki so obnovitveni odmerek prejeli 18 mesecev po prvi seriji odmerkov.
Data on safety of a booster dose of the current Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics formulation are limited to three trials (V87P1, V87P2 and V87P1E1) that included 116 adults and 56 elderly.
Podatki o varnosti obnovitvenega odmerka trenutne formulacije cepiva Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics so omejeni na tri preskušanja (V87P1, V87P2 in V87P1E1), v katera je bilo vključenih 116 odraslih in 56 starejših oseb.
Groups of 8 ferrets received one (day 21) or two (days 0 and 21) doses of vaccine containing 3.75 or 7.5 micrograms of antigen.
8 dihurjev v skupini je prejelo en (21. dan) ali dva (0. in 21. dan) odmerka cepiva, ki je vsebovalo 3,75 ali 7,5 mikrograma antigena.
Method of administration Immunisation should be carried out by intramuscular injection into the deltoid muscle.
Način uporabe Imunizacija se opravi z intramuskularnim injiciranjem v deltoidno mišico.
nd 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*.
A lethal challenge was administered by the intratracheal route on day 49.
Ţivali so 49. dan prejele letalno provokacijo prejele po intratrahealni poti.
Animals were challenged by the intranasal route on day 42 with a lethal dose of A/Vietnam/1203/04 virus.
Ţivali so intranazalno 42. dan prejele letalen odmerek virusa A/Vietnam/1203/04.
Groups of 6 ferrets received one dose of vaccine (day 21) containing 3.75 micrograms of antigen or two doses of vaccine (days 0 and 21) containing either 1.0 or 3.75 micrograms of antigen (A/Vietnam/1194/2004).
Skupine 6 dihurjev so prejele en odmerek cepiva (21. dan), ki je vseboval 3,75 mikrograma antigena ali dva odmerka cepiva (0. in 21. dan), ki je vseboval bodisi 1,0 ali 3,75 mikrograma antigena (A/Vietnam/1194/2004).
The vaccine will be injected into the muscles of the upper arm (deltoid muscle).
Cepivo se injicira v mišico nadlakta (v deltoidno mišico).
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION
IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA,
Toddlers (6-<36 months) Children (3-<9 years) Adolescents (9-<18 years) N=91
Otroci (3-<9 let) Mladostniki (9-<18 let)
Neurological disorders, such as encephalomyelitis, and Guillain Barré syndrome.
Bolezni ţivčevja Nevrološke bolezni kot so encefalomielitis in Guillain Barréjev sindrom
Neurological disorders such as severe stabbing or throbbing pain along one or more nerves, tingling, fits, and neuritis (inflammation of nerves).
Nevrološke motnje kot so zbadanje ali prebijajoča bolečina vzdolţ enega ali več ţivcev, mravljinčenje, krči in nevritis (vnetje ţivcev).
Skin and subcutaneous tissue disorders Common: sweating Uncommon: urticaria Rare: eye swelling
Bolezni koţe in podkoţja Pogosti: znojenje Občasni: urtikarija Redki: otekanje oči
Adjuvant MF59C.1 containing: squalene
- Adjuvans MF59C.1:
Muscoskeletal, connective tissue and bone disorders Very common: myalgia
Bolezni mišično-skeletnega sistema, vezivnega tkiva in kosti Zelo pogosti: mialgija
Palpitation, tachycardia.
Srčne bolezni palpitacije, tahikardija
MN results for the three clinical studies in the Table above revealed a seroprotection rate and seroconversion rate against A/turkey/Turkey/05 ranging from 10% (2-27) to 39% (32-46) and 10% (227) to 36% (29-43) respectively.
Rezultati MN za tri klinične študije v zgornji preglednici kaţejo na stopnjo serozaščite proti sevu A/turkey/Turkey/05 v razponu od 10 % (2-27) do 39 % (32-46), in na stopnjo serokonverzije proti temu sevu med 10 % (2-27) in 36 % (29-43).
Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Nevrološke bolezni kot so nevralgija, parestezija, konvulzije in nevritis
Information from non-clinical trials
Informacije iz predkliničnih preskušanj
Muscoskeletal, connective tissue and bone disorders Muscular weakness, pain in extremities.
Bolezni mišično-skeletnega sistema, vezivnega tkiva in kosti Oslabelost mišic, bolečine v okončinah
Headache, dizziness, somnolence, syncope.
Glavobol, vrtoglavica, zaspanost, sinkopa.
The other ingredients are: sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.
Pomoţne snovi so: natrijev klorid; kalijev klorid; kalijev dihidrogen fosfat; dinatrijev fosfat dihidrat; magnezijev klorid heksahidrat; kalcijev klorid dihidrat, natrijev citrat, citronska kislina in voda za injekcije
It is intended to be given before or during the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus.
Namenjeno je za preprečevanje gripe, ki jo povzroča tip virusa H5N1, pred naslednjo pandemijo influence (gripe) ali med njo.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics 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 Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics je bilo ovrednoteno pri zdravih odraslih (starih med 18 in 60 let) in zdravih starejših odraslih (starih več kot 60 let) po reţimu primarnega cepljenja 1. in 22. dan in obnovitveno cepljenje (glejte poglavji 4.8 in 5.1).
In such cases, you should be aware that the side effects may be more intense.
V takih primerih so lahko neţeleni učinki okrepljeni.
A minor infection such as a cold should not be a problem, but your doctor or nurse should advise whether you could still be vaccinated with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated,
Blaţja okuţba kot je prehlad ne predstavlja teţave, vendar vam bosta zdravnik ali medicinska sestra svetovala, ali se lahko še vedno cepite s cepivom Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics,
Pain, hardening of the skin at the injection site, injection site redness, injection site swelling, pain at the site of injection, aching muscles, headache, sweating, fatigue.
Bolečina, otrdelost koţe na mestu injiciranja, pordečeno in oteklo mesto injiciranja, bolečina na mestu injiciranja, bolečine v mišicah, glavobol, zvečano potenje, utrujenost
Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event
vsi lokalni sistemski zvišana telesna temperature ≥ 38 °C (≥ 40 °C) vsi drugi neţeleni učinki
A clinical trial (Study V87P6) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 471 children from 6 months to 17 years of age.
Opravili so klinično preskušanje (študija V87P6) za kombinacijo cepiva H5N1 in adjuvansa MF59C.1 pri 471 otrocih, starih od 6 mesecev do 17 let.
Since a second dose is recommended, it should be noted that there are no safety, immunogenicity or efficacy data to support interchangeability of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics with other H5N1 monovalent vaccines.
Ker je priporočljivo cepljenje z drugim odmerkom, je treba opozoriti, da ni podatkov o varnosti, imunogenosti ali učinkovitosti, ki podpirajo zamenljivost cepiva Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics z drugimi monovalentnimi cepivi H5N1.
Immunization shall be postponed in patients with febrile illness or acute infection.
Imunizacijo pri bolnikih s povišano telesno temperaturo ali akutno okuţbo je treba preloţiti.
Some cross-protection was observed against related H5N1 virus variants in clinical trials (see section
V kliničnih preskušanjih so opazili določeno stopnjo navzkriţne zaščite proti različicam virusa H5N1 (glejte poglavje 5.1).
MN results against a A/Vietnam/1194/2004 indicate a seroprotection rate of 99% (95%CI: 94-100), a seroconversion rate ranging from 97% (95%CI: 91-99) to 99% (95%CI: 96-100) and a GMR ranging from 29 (95%CI: 25-35) to 50 (95%CI: 44-58).
Rezultati MN za sev A/Vietnam/1194/2004 kaţejo na stopnjo serozaščite 99 % (95-odstotni IZ: 94100), stopnjo serokonverzije v razponu od 97 % (95-odstotni IZ: 91-99) do 99% (95-odstotni IZ: 96100) in GMR v razponu od 29 (95-odstotni IZ: 25-35) do 50 (95-odstotni IZ: 44-58).
* measured by SRH assay ≥ 25 mm2 ** geometric mean ratios of SRH
* izmerjeno s testom SRH ≥ 25 mm ** razmerja geometričnih srednjih vrednosti za SRH
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 residues (eggs and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)).
Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaktične reakcije) na zdravilno učinkovino, katerokoli pomoţno snov ali snov v sledovi (jajčne ali piščančje beljakovine, ovalbumin, kanamicinsulfat in neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid (CTAB)).
Generalised skin reactions including itching, urticaria (hives), rash or swelling of the skin and mucous membranes.
Generalizirana koţna reakcija vključno s srbenjem, urtikarijo (koprivico), izpuščajem ali oteklino koţe in sluznice.
The incidence of adverse reactions has been evaluated in six clinical trials involving approximately 4,000 adults and elderly receiving (Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics at least 7.5 µg HA, adjuvanted).
Pogostnost neţelenih učinkov so ocenili v šestih kliničnih preskušanjih, ki je zajela pribliţno 4.000 odrasnih in starejših oseb, ki so prejele cepivo Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (vsaj 7,5 µg HA, z adjuvansom).
Very limited data in subjects with co-morbidities, including immunocompromised subjects are available for this H5N1 vaccine.
Za to cepivo H5N1 so na voljo zelo omejeni podatki za osebe s sočasnimi boleznimi, vključno z osebe z oslabljenim imunskim sistemom.
In another clinical trial (Study V87P13) 2693 adult subjects were enrolled and received two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/dose adjuvanted) administered three weeks apart.
V drugem kliničnem preskušanju (študija V87P13) so vključili 2.693 odraslih, ki je v 3-tedenskem presledku prejelo dva odmerka cepiva, ki vsebuje H5N1 (A/Vietnam/1194/2004; 7,5 µg HA/odmerek z adjuvansom).
Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Bolezni koţe in podkoţja generalizirane koţne reakcije vključno s pruritusom, urtikarijo ali nespecifičnim izpuščajem; Angioedem
Name and address of the manufacturers of the biological active substance Novartis Vaccines and Diagnostics S.r.l.
Ime in naslov izdelovalcev biološke zdravilne učinkovine Novartis Vaccines and Diagnostics S.r.l.