natgillin/translations-raw huggingface dataset:
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).
Nízky počet krvných doštičiek v krvi, čo môţe spôsobiť krvácanie alebo vznik podliatin Vaskulitída (zápal krvných ciev, ktorý môţe spôsobovať koţné vyráţky, bolesť kĺbov a problémy s obličkami), exudatívny multiformný erytém (typ alergickej koţnej reakcie, ktorá sa vyskytuje ako odpoveď na liečbu, infekciu alebo ochorenie).
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 týţdňoch po 2. očkovaní (43. deň) všetky vekové skupiny (t.j. 6-35 mesiacov, 3-8 rokov a 9-17 rokov) dosiahli vysoké hladiny protilátok voči (A/Vietnam/1194/2004), ako bolo vyhodnotené SRH a HI analýzami a je uvedené v tabuľke niţšie*.
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,
Mierna infekcia, akou je prechladnutie, by nemala byť problémom, Váš lekár alebo zdravotná sestra posúdi, či máte byť očkovaný vakcínou Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Intramuscular use
Intramuskulárne pouţitie
Day 43 to Day 1 % SC (95% CI)
43. deň aţ 1. deň % SK (95 % CI)
1.175 milligrams per 0.5 ml sorbitan trioleate
1,175 miligramu na 0,5 ml sorbitantrioleát
* measured by SRH assay ≥ 25 mm2 ** geometric mean ratios of SRH
* merané SRH analýzou ≥ 25 mm ** geometrický priemer pomerov SRH
Use in children There is limited experience in children between 6 months and 17 years of age.
Pouţitie u detí Skúsenosti s pouţitím u detí vo veku od 6 mesiacov do 17 rokov sú obmedzené.
“Possible side effects” may affect the ability to drive or use machines.
Niektoré účinky uvedené v časti 4 „Moţné vedľajšie účinky“ môţu mať vplyv na schopnosť viesť vozidlá alebo obsluhovať stroje.
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).
Táto indikácia je zaloţená na údajoch o imunogenite u zdravých osôb vo veku od 18 rokov po podaní dvoch dávok vakcíny obsahujúcej variant kmeňa A/Vietnam/1194/2004(H5N1)
A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14) 7.5 micrograms haemagglutinin Adjuvant: MF59C.1 oil composed of squalene, polysorbate 80 and sorbitan trioleate.
(H5N1)-variant kmeňa (NIBRG-14) 7,5 mikrogramov hemaglutinínu Adjuvans: MF59C.1 obsahujúci ako olejovú fázu skvalén, polysorbát 80 a sorbitantrioleát.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION
VÝROBCOVIA BIOLOGICKÉHO LIEČIVA A DRŢITEĽ POVOLENIA NA VÝROBU ZODPOVEDNÝ
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).
Novartis Vaccines and Diagnostics bola hodnotená u zdravých dospelých (vo veku 18-60 rokov) a zdravých starších osôb (starších ako 60 rokov) podľa plánu základného očkovania 1. a 22.deň a podľa preočkovania (pozri časti 4.8 a 5.1).
STATEMENT OF ACTIVE SUBSTANCE One dose of 0.5 ml contains: Active Ingredients: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in eggs, of strain:
Jedna dávka 0,5 ml obsahuje: Liečivá: Povrchové antigény vírusu chrípky (hemaglutinín a neuraminidáza), pomnoţené vo vajciach, kmeňa:
MARKETING AUTHORISATION NUMBER EU/1/10/657/001 1 prefilled syringe EU/1/10/657/002 10 prefilled syringes
1 naplnená injekčná striekačka EU/1/10/657/002
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 očkovaní proti chrípke sa môţu vyskytnúť falošne pozitívne výsledky v sérologických testoch pouţívajúcich metódu ELISA na zistenie protilátok na vírus ľudskej imunodeficiencie-1
Common: Brusing of the skin at the injection site, fever and nausea, generally feeling unwell and shivering.
Časté: Podliatina v mieste vpichu, horúčka a nevoľnosť, celkový pocit choroby a chvenie.
Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Sodium citrate,
Chlorid sodný, chlorid draselný, dihydrogenfosforečnan draselný, dihydrát hydrogenfosforečnanu sodného, hexahydrát chloridu horečnatého, dihydrát chloridu vápenatého, citrát sodný, kyselina citrónová, voda na injekciu.
(H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics dose, SRH CHMP criteria were achieved in all the vaccine schedule groups after 3 weeks from the 2nd vaccination.
Novartis Vaccines and Diagnostics, boli dosiahnuté SRH kritériá CHMP vo všetkých skupinách s očkovacími schémami po 3 týţdňoch od 2. očkovania.
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.
Novartis Vaccines and Diagnostics sú obmedzené na tri štúdie (V87P1, V87P2 a V87P1E1), ktorých sa zúčastnilo 116 dospelých a 56 starších osôb.
For the adjuvant, see section 2
Ohľadom adjuvans, pozri časť 2. 6.2 Inkompatibility
Loc. Bellaria - 53018 Rosia - Sovicille (SI)
Bellaria - 53018
In a clinical trial evaluating 4 different vaccination schedules in 240 subjects 18 to 60 years of age, where the second dose was after either 1, 2, 3 or 6 weeks after the first Prepandemic Influenza vaccine
V klinickej skúške hodnotiacej 4 rôzne očkovacie schémy u 240 osôb vo veku 18 aţ 60 rokov, ktorým bola druhá dávka podaná v 1, 2, 3 alebo 6 týţdňoch po prvej dávke vakcíny Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/dose adjuvanted) were administered three weeks apart to 156 healthy adults.
(A/Vietnam/1194/2004, adjuvantná dávka 7,5 µg HA) boli podané v intervale troch týţdňov 156 zdravým dospelým osobám.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5 ml
OBSAH V HMOTNOSTNÝCH, OBJEMOVÝCH ALEBO V KUSOVÝCH JEDNOTKÁCH
In a phase 2 clinical trial (Study V87P3) adult subjects aged 18-65 years primed 6-8 years previously with 2 doses of MF59-adjuvanted H5N3 vaccine /A/Duck/Singapore/97 were administered 2 booster doses of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics SRH results after the first dose, that mimic prepandemic priming plus single heterologous booster dose, met all CHMP criteria.
V 2. fáze klinického skúšania (štúdia V87P3) boli dospelým osobám vo veku 18-65 rokov, ktoré boli očkované pred 6-8 rokmi 2 dávkami vakcíny H5N3 s adjuvans MF59 /A/Duck/Singapore/97 podané dve dávky vakcíny Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
The following additional adverse events were reported from post-marketing surveillance with Focetria H1N1v (licensed for use from 6 months of age and with a composition that is similar to Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics):
Nasledujúce neţiaduce reakcie boli hlásené počas postmarketingového sledovania vakcíny Focetria H1N1v (schválenej na pouţitie od 6 mesiacov veku a s podobným zloţením ako má vakcína Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Name and address of the manufacturer responsible for batch release Novartis Vaccines and Diagnostics S.r.l.
Názov a adresa výrobcu zodpovedného za uvoľnenie šarţe Novartis Vaccines and Diagnostics S.r.l.
Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics alone.
Súbeţné podanie nesúviselo s vyššou mierou výskytu lokálnych alebo systémových reakcií v porovnaní s podávaním samotnej vakcíny Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)) of this vaccine.
j. ţivot ohrozujúcej) reakcie na ktorékoľvek zloţky alebo stopové mnoţstvá (vaječné a kuracie bielkoviny, ovalbumín, kanamycín a neomycínsulfát, formaldehyd a cetyltrimetylamóniumbromid (CTAB)) tejto vakcíny.
A single vaccination with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (H5N1, A/Vietnam/1194/2004) induced high and rapid serological response in subjects primed 6-8 years previously with two doses of a different surrogate H5N vaccine, having same formulation as Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics but using the strain H5N3.
Novartis Vaccines and Diagnostics (H5N1, A/Vietnam/1194/2004) vyvolalo vysokú a rýchlu sérologickú odpoveď u osôb očkovaných pred 6-8 rokmi dvoma dávkami inej podobnej H5N vakcíny, ktorá má rovnaké zloţenie ako Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe.
Injekčná suspenzia v naplnenej injekčnej striekačke.
Non-clinical data obtained with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics and with seasonal influenza vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of repeated dose toxicity, local tolerance, female fertility, and reproductive and developmental toxicity (through the end of the lactation period).
Novartis Vaccines and Diagnostics a sezónnou vakcínou proti chrípke obsahujúcou adjuvans MF59C.1 na základe obvyklých farmakologických štúdií toxicity po opakovanom podávaní, lokálnej znášanlivosti, plodnosti u ţien, reprodukčnej toxicity a vývinu (ku koncu obdobia laktácie) neodhalili ţiadne osobitné riziko pre ľudí.
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).
Výskyt neţiaducich reakcií bol hodnotený v šiestich klinických štúdiách, ktorých sa zúčastnilo pribliţne 4000 dospelých a starších osôb, ktorým bola podaná vakcína Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis
- ak ste niekedy mali závaţnú ţivot ohrozujúcu alergickú reakciu na ktorúkoľvek zloţku vakcíny Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Adverse reactions from clinical trial in children (6 months to 17 years old) (Study V87P6)
Neţiaduce reakcie z klinických skúšaní u detí (vo veku 6 mesiacov aţ 17 rokov)
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.
V prípade podania druhej dávky je potrebné vziať do úvahy, ţe neexistujú ţiadne údaje o bezpečnosti, imunogenite, ani údaje o účinnosti, ktoré by podporili zameniteľnosť vakcíny Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
It is estimated that more than 90,000 women have been vaccinated during pregnancy with H1N1v vaccine Focetria which contains the same amount of adjuvant MF59C.1 as. Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics However information on outcomes is currently limited.
Predpokladá sa, ţe viac ako 90 000 ţien bolo počas gravidity očkovaných s H1N1 vakcínou Focetria, ktorá obsahuje rovnaké mnoţstvo adjuvans MF59C.1 ako vakcína Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Palpitation, tachycardia.
Poruchy srdca a srdcovej činnosti Palpitácia, tachykardia.
• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to egg and, chicken protein, ovalbumin, formaldehyde,
- ak ste niekedy mali alergickú reakciu, inú neţ náhlu, ţivot ohrozujúcu reakciu na ktorúkoľvek zo zloţiek obsiahnutých vo vakcíne, vaječnú a kuraciu bielkovinu, ovalbumín, formaldehyd, kanamycín a neomycínsulfát (antibiotiká), alebo cetyltrimetylamóniumbromid (CTAB)
** geometric mean ratios of SRH ° measured by HI assay ≥ 40 °° geometric mean ratios of HI
° merané HI analýzou ≥ 40 °° geometrický priemer pomerov HI
The magnitude of immune response was lower in the group who received the 2
Rozsah imunitnej odpovede bol niţší v skupine, ktorá dostala 2. dávku po 1 týţdni a vyšší v skupinách s dlhšími intervalmi v rámci očkovacej schémy.
% SP (95% CI) Day 43
% SK (95 % CI)
Vaccines and Diagnostics (these are listed at the end of the leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin,
Vaccines and Diagnostics (sú uvedené na konci tejto písomnej informácie pre pouţívateľov) alebo iné zloţky, ktoré môţu byť prítomné v stopových mnoţstvách, napr.: vaječná a kuracia bielkovina, ovalbumín, formaldehyd, kanamycín a neomycínsulfát (antibiotiká), alebo cetyltrimetylamóniumbromid (CTAB).
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14)
Povrchové antigény vírusu chrípky (hemaglutinín a neuraminidáza)* kmeňa: A/Vietnam/1194/2004
Skin and subcutaneous tissue disorders Common: sweating Uncommon: urticaria Rare: eye swelling
Menej časté: ţihľavka Zriedkavé: opuch oka
A clinical trial (Study V87P1) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 312 healthy adults.
Bolo vykonané klinické skúšanie (štúdia V87P1) s vakcínou H5N1 kombinovanou s adjuvans MF59C.1
Study V87P2 Adults booster after 2rd dose
Štúdia V87P2Dospelí preočkovanie po 2. dávke
RELEASE
VÝDAJA
adjuvanted) Novartis Vaccines and Diagnostics;
Novartis Vaccines and Diagnostics):
Any
A
Common: arthralgia
Zriedkavé: anafylaxia
Two doses of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics were administered three weeks apart and a third dose 12 months following the first dose.
Novartis Vaccines and Diagnostics boli podané v intervale troch týţdňov a tretia dávka 12 mesiacov po prvej dávke.
Loc. Bellaria - 53018 Rosia Sovicille (SI), Italy.
Rosia Sovicille (SI), Taliansko.
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)**
Miera sérokonverzie (95 % CI)*
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
VÝROBCOVIA BIOLOGICKÉHO LIEČIVA A DRŢITEĽ POVOLENIA NA VÝROBU ZODPOVEDNÝ ZA UVOĽNENIE ŠARŢE
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine for use in adults (from 18 to 60 years old).
Novartis Vaccines and Diagnostics je vakcína určená na pouţitie pre dospelých (od 18 do 60 rokov) a staršie osoby (staršie ako 60 rokov).
General disorders and administration site conditions Very common: injection site swelling, injection site pain, injection site induration, injection site redness, fatigue
Veľmi časté: opuch v mieste vpichu, bolesť v mieste vpichu, stvrdnutie v mieste vpichu, sčervenanie miesta vpichu, únava
The following additional adverse events were reported from post-marketing surveillance with seasonal non-adjuvanted trivalent vaccines in all age groups and an MF59 seasonal adjuvanted trivalent vaccine with a composition similar to Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (surface antigen, inactivated, adjuvanted with MF59C.1) that is licensed for use in elderly subjects 65 years of age and older: Blood and lymphatic system disorders
Počas postmarketingových prieskumov so sezónnymi neadjuvantnými trivalentnými vakcínami vo všetkých vekových skupinách a so sezónnou trivalentnou vakcínou a adjuvans MF59 s podobným zloţením ako Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
MN results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from of 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69) respectively.
Výsledky MN voči A/Vietnam/1194/2004 indikujú mieru séroprotekcie, mieru sérokonverzie v rozsahu 57 % (50-64) aţ 79 % (68-87)
Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event Children (3-<9 years)
Akékoľvek iné neţiaduce účinky Deti (3 aţ <
Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event Adolescents(9-<18 years)
Akékoľvek iné neţiaduce účinky Adolescenti (9 aţ <
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.
Bolo vykonané klinické skúšanie (štúdia V87P6) vakcíny H5N1 kombinovanej s adjuvans MF59C.1
All (100%) animals receiving 2 doses of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics were protected, and 94% of animals receiving a single dose of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics were protected.
Novartis Vaccines and Diagnostics boli chránené a 94 % zvierat dostávajúcich jednu dávku vakcíny Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics containing HA from A/Vietnam/1194/2004 (homologous to the challenge strain) and an Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics -like H5N1 vaccine, containing hemagglutinin from the A/turkey/Turkey/1/2005-like (heterologous to the challenge strain) were tested.
Novartis Vaccines and Diagnostics, obsahujúca HA z A/Vietman/1194/2004 (homológna na stimulujúci kmeň) a vakcína podobná vakcíne Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
7.5 micrograms** per 0.5 ml dose
(H5N1)-variant kmeňa (NIBRG-14) 7,5 mikrogramu** na 0,5 ml dávku
Limited data was obtained from women who became pregnant with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics during the course of clinical trials.
Obmedzené údaje boli získané u ţien, ktoré otehotneli počas priebehu klinickej štúdie vakcíny Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14)
A/Vietnam/1194/2004
Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2
Miera séroprotekcie*, miera sérokonverzie* a faktor sérokonverzie** pre anti-HA protilátky voči H5N1 A/turkey/Turkey/05 boli po podaní 2. dávky u dospelých vo veku 18-60 rokov merané SRH a HI analýzami nasledujúce:
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)** * measured by SRH assay ≥ 25 mm2
Faktor sérokonverzie (95 % CI)**
A third (booster) dose of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics was administered 6 months onwards after the primary vaccination.
Novartis Vaccines and Diagnostics (preočkovanie) bola podaná 6 mesiacov a viac po základnom očkovaní.
Muscoskeletal, connective tissue and bone disorders Very common: myalgia
Poruchy koţe a podkoţného tkaniva Časté: potenie
Do not use Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics after the expiry date which is stated on the carton and the label.
Novartis Vaccines and Diagnostics po dátume exspirácie, ktorý je uvedený na škatuli a štítku.
ANTIGEN, INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND
(SURFACE ANTIGEN, INACTIVATED, ADJUVANTED)
Prepandemic Influenza vaccine (H5N1) (surface antigen, inativated, adjuvanted)
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
In the event of an officially declared influenza pandemic due to A/H5N1 virus, persons previously vaccinated with one or two doses of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics that contained HA antigen derived from a different clade of the same influenza subtype as the influenza pandemic strain may receive a single dose of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics instead of two doses that are required in previously unvaccinated individuals (see section 5.1).
V prípade oficiálne vyhlásenej chrípkovej pandémie spôsobenej vírusom A/H5N1 osobám v minulosti očkovaným jednou alebo dvomi dávkami vakcíny Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Rare: Convulsions, eye swelling and anaphylaxis.
Kŕče, opuch oka a anafylaxia.
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics suspension for injection in pre-filled syringe Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Novartis Vaccines and Diagnostics a obsah balenia Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Lymphadenopathy.
ZATRIEDENIE LIEKU
In the first few weeks after vaccination with Prepandemic Influenza vaccine (H5N1) (surface antigen,
V prvých týţdňoch po očkovaní vakcínou Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
These side effects may occur with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Tieto vedľajšie účinky môţu vyskytnúť aj po vakcíne Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Water for injections.
Injekčná suspenzia.
• in the presence of immune deficiencies Prepandemic Influenza vaccine (H5N1) (surface antigen,
- v prípade imunologických porúch môţe byť podaná vakcína Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Important information about some of the ingredients of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Dôleţité informácie o niektorých zloţkách Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Therefore the data indicate that Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Novartis Vaccines and Diagnostics sa môţe podávať súbeţne s neadjuvantnými sezónnymi vakcínami proti chrípke (podaním injekcie do opačnej končatiny).
Transient thrombocytopenia.
Poruchy krvi a lymfatického systému Prechodná trombocytopénia.