natgillin/translations-raw huggingface dataset:
Side effects observed with a similar influenza vaccine (Celvapan) The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and children during the H1N1 pandemic flu vaccination programme:
Neželeni učinki, ugotovljeni pri podobnem cepivu proti gripi (Celvapan) Neželeni učinki, navedeni v nadaljevanju, so se pojavili pri podobnem cepivu proti gripi (Celvapan) pri odraslih in otrocih v programu cepljenja proti pandemski gripi H1N1:
Adverse Reactions (infants, children and adolescents)
Neželeni učinki (dojenčki, otroci in mladostniki)
ACTIVE SUBSTANCE A/Vietnam/1203/2004 (H5N1)
A/Vietnam/1203/2004 (H5N1)
Infants, children, and adolescents Immune response against A/Vietnam/1203/2004 (H5N1)
Dojenčki, otroci in mladostniki Odziv imunskega sistema na sev A/Vietnam/1203/2004 (H5N1)
Ferrets vaccinated with the 7.5 µg dose of the A/Vietnam/1203/2004 vaccine demonstrated a high rate of seroconversion.
Dihurji, cepljeni z odmerkom 7,5 µg cepiva A/Vietnam/1203/2004, so pokazali visoko stopnjo serokonverzije.
Infants and children aged 6 to 35 months: In a clinical trial the H5N1 vaccine was administered to 36 infants and children aged 6 to 35 months.
Dojenčki in otroci, stari od 6 do 35 mesecev: V kliničnem preskušanju je cepivo proti H5N1 prejelo 36 dojenčkov in otrok, starih od 6 do 35 mesecev.
Animal reproductive and developmental toxicology studies do not indicate harmful effects in regard to female fertility, embryo-foetal and pre- and post-natal toxicity.
Študije vpliva na sposobnost razmnoževanja in razvoj pri živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost samic, brejost, razvoj zarodka/plodu, kotitev ali postnatalni razvoj.
1 dose (0.5 ml) contains:
1 odmerek (0,5 ml) vsebuje:
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,
Po cepljenju proti gripi je prišlo do lažno pozitivnih rezultatov seroloških testov, ki so bili izvedeni po metodi ELISA za odkrivanje protiteles proti človeškemu virusu imunske pomanjkljivosti 1 (HIV-1),
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Baxter AG
- if you have a bleeding problem or bruise easily.
- če imate težave s krvavitvami oz. strjevanjem krvi ali vam že pri rahlem udarcu nastanejo modrice.
One dose of 0.5 ml at an elected date.
En odmerek 0,5 ml naj bo injiciran na izbran datum.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VEPACEL suspension for injection
IME ZDRAVILA IN POT(I) UPORABE VEPACEL suspenzija za injiciranje
- if you have a weakened immune system as for example because of immunosuppressive therapy, e.g. taking of corticosteroids or treatment for cancer.
- če imate oslabljen imunski sistem, na primer zaradi imunosupresivnega zdravljenja z zdravili,
• injection-site reaction such as irritation, itching, bruising or stiff arm
• reakcija na mestu injiciranja, kot so draženje, srbenje, podplutba ali otrdelost roke.
21 Days after 2nd Dose
21 dni po drugem odmerku 21 dni po drugem odmerku
Seroneutralisation rate* Seroconversion rate** Seroconversion factor*** * MN titre ≥ 20 ** ≥ 4-fold increase in MN titre *** geometric mean increase
Odstotek seronevtralizacije* Odstotek serokonverzije** Faktor serokonverzije*** * titer MN ≥ 20 ** ≥ 4-kratno povečanje titra MN *** geometrična sredina povečanja
* produced in Vero cells ** haemagglutinin
* pripravljen v celicah Vero **hemaglutinina
Immune system disorders: anaphylactic reaction, hypersensitivity Nervous system disorders: febrile convulsion Skin and subcutaneous tissue disorders: angioedema Muscoluskeletal and connective tissue disorders: pain in extremity
Bolezni imunskega sistema: anafilaktična reakcija, preobčutljivost Bolezni živčevja: febrilne konvulzije Bolezni kože in podkožja: angioedem
60 years and above Strain A/Indonesia/05/2005 21 Days after 2nd Dose
60 let in več Sev A/Indonesia/05/2005
VEPACEL should not be given at the same time as immunoglobulins.
Cepiva VEPACEL ne uporabljajte hkrati z imunoglobulini.
After first opening, the vaccine should be used immediately (within 3 hours maximum).
Po prvem odprtju cepivo uporabite nemudoma (v največ 3 urah).
• stomach pain, upset stomach
• bolečine v trebuhu, prebavne motnje,
1 pre-filled syringe (0.5 ml)
1 napolnjena injekcijska brizga (0,5 ml)
Heterologous booster vaccinations
Heterologna poživitvena cepljenja
MINIMUM PARTICULARS ATTACHED TO THE OUTER CARTON OF MULTIDOSE CONTAINER AND PRE-FILLED SYRINGE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI IN SO PRIPETI NA ZUNANJO ŠKATLO VEČODMERNEGA VSEBNIKA IN NAPOLNJENE INJEKCIJSKE BRIZGE
After first opening, the vaccine should be used immediately (within a maximum period of 3 hours).
Po prvem odprtju cepivo uporabite nemudoma (v največ 3 urah)
In addition, during a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Poleg tega med trajanjem pandemije, viri, potrebni za poglobljeno vrednotenje rednih posodobljenih poročil o varnosti zdravila v obliki, kot je definirana v Pravilih, ki urejajo zdravila v Evropski skupnosti (”Rules Governing Medicinal Product in the
a) The following side effects have been reported in a clinical study in infants aged 6 to 35 months.
a) V klinični študiji so poročali o naslednjih neželenih učinkih pri dojenčkih, starih od 6 do 35 mesecev.
1 pack of a pre-filled syringe containing a single dose of 0.5 ml suspension for injection with a latex-free plunger (halogeno-butyl-rubber) without needles.
1 zavitek napolnjeni brizgi, ki vsebuje en odmerek 0,5 ml suspenzije za injiciranje z batom brez lateksa (halogeno-butil-guma) brez igle.
Infants, children and adolescents from the age of 6 months to 17 years and adults from the age of 18 years:
Dojenčki, otroci in mladostniki, stari od 6 mesecev do 17 let in odrasle osebe, stare 18 let in več: Daje se en odmerek po 0,5 ml.
Prepandemic influenza vaccine (H5N1)
Predpandemsko cepivo proti gripi (H5N1) i.m.
There are no data on co-administration of VEPACEL with other vaccines.
Ni podatkov o sočasnem cepljenju s cepivom VEPACEL in drugimi cepivi.
Sensory disturbance (paresthesia, dysesthesia, oral dysesthesia, hypoesthesia, dysgeusia, and burning sensation)
hipestezija, oralna disestezija, disgevzija in pekoč občutek)
21 Days after 1st Dose 2nd Dose 1st Dose 2nd Dose 1st Dose 2nd Dose
1. odmerku 2. odmerku 1. odmerku 2. odmerku
PEEL OFF´S (1 PEEL OFF PER DOSIS)
ODSTRANLJIVE NALEPKE (1 ODSTRANLJIVA NALEPKA NA ODMEREK)
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Navodilo je bilo nazadnje revidirano dne {MM/LLLL} Podrobne informacije o cepivu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
After first opening, the vaccine should be used immediately.
Cepivo uporabite nemudoma po prvem odprtju.
Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.
Vsak odmerek cepiva 0,5 ml posesajte v brizgo za injiciranje.
How VEPACEL is given
Kako se cepivo VEPACEL daje
4.7 Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji VEPACEL ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
• flu-like illness
• gripi podobna bolezen,
INFECTIONS AND INFESTATIONS
INFEKCIJSKE IN PARAZITSKE BOLEZNI
One pack of 20 multidose vials (type I glass) of 5 ml suspension (10 x 0.5 ml doses) with a stopper (bromobutyl rubber).
Eno pakiranje po 20 večodmernih vsebnikov (iz stekla vrste I) s 5 ml suspenzije (10 odmerkov po 0,5 ml) z zamaškom (iz bromobutilne gume).
• insomnia (difficulty sleeping)
• otečene žleze, • nespečnost (težave pri spanju),
VEPACEL is presented as a suspension for injection in a pre-filled syringe.
VEPACEL je na voljo kot suspenzija za injiciranje v napolnjeni injekcijski brizgi.
You should not receive VEPACEL
Cepiva VEPACEL ne smete prejeti
Urticaria
VEPACEL
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 10 DOSE VIAL
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - VIALA Z 10 ODMERKI
Very rare (affects less than 1 user in 10,000):
Zelo redki (pojavijo se pri manj kot 1 od 10.000 oseb):
MARKETING AUTHORISATION NUMBER EU/1/12/752/002
EU/1/12/752/002
12 - 24 months booster
Poživitveno cepljenje po 12 do 24 mesecih
The immunogenicity of the A/Vietnam/1203/2004 strain vaccine has been evaluated in a clinical trial in children and adolescents aged 9 to 17 years (N=288), in children aged 3 to 8 years (N=146) and in infants and children aged 6 to 35 months (N=33) following a 0, 21 day schedule.
Imunogenost cepilnega seva A/Vietnam/1203/2004 je bila ocenjena v kliničnem preskušanju pri otrocih in mladostnikih, starih od 9 do 17 let (N=288), pri otrocih, starih od 3 do 8 let (N=146) ter dojenčkih in otrocih, starih od 6 do 35 mesecev (N=33), po shemi cepljenja 0. in 21. dan.
SKIN AND
KOŽE IN PODKOŽJA
Ireland
Avstrija
• irritability
• razdražljivost.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BOLEZNI MIŠIČNO-SKELETNEGA SISTEMA IN VEZIVNEGA TKIVA
neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome
• nevrološke motnje, kot so encefalomielitis (vnetje osrednjega živčnega sistema), nevritis (vnetje živcev) in vrsta paralize, ki ji pravimo Guillain-Barréjev sindrom.
VEPACEL may affect your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Cepivo VEPACEL lahko vpliva na sposobnost vožnje in upravljanja s stroji.
The observed adverse reactions from a paediatric clinical trial with the H5N1 vaccine are listed below.
V nadaljevanju so navedeni neželeni učinki, opaženi v pediatričnem kliničnem preskušanju cepiva proti H5N1.
MARKETING AUTHORISATION NUMBER EU/1/12/752/001
EU/1/12/752/001
Cross-reactive immune response against related H5N1 strains In a clinical study in adults aged 18 to 59 years (N=265) and in older people aged 60 years and above (N=270) after vaccination with the A/Vietnam/1203/2004 strain vaccine, the rate of subjects with cross-neutralising antibodies as measured by MN (titre ≥ 20) was as follows:
V klinični študiji pri odraslih, starih od 18 do 59 let (N=265), in starejših osebah, starih 60 let in več (N=270) je bil po cepljenju s cepivom iz seva A/Vietnam/1203/2004 odstotek oseb z navzkrižnimi nevtralizacijskimi protitelesi, izmerjen z mikronevtralizacijo (titer ≥ 20), naslednji:
VEPACEL is presented as a suspension for injection in multidose vial (10 doses of 0.5 ml per vial) in pack size of 20 vials.
Kaj VEPACEL izgleda in vsebina pakiranja VEPACEL je na voljo kot suspenzija za injiciranje v večodmernem viali (10 odmerkov po 0,5 ml) v pakiranjih po 20 vial.
Immune response against A/Vietnam/1203/2004 (H5N1) The immunogenicity of the A/Vietnam/1203/2004 strain vaccine has been evaluated in three clinical studies in adults aged 18 - 59 years (N=961) and in two clinical studies in subjects aged 60 years and older (N=391) following a 0, 21 day schedule.
Imunogenost cepilnega seva A/Vietnam/1203/2004 je bila ocenjena v treh kliničnih študijah pri odraslih, starih od 18 do 59 let (N=961) in v dveh kliničnih študijah pri starostnikih, starih 60 let in več (N=391), in sicer po shemi cepljenja 0. in 21. dan.
Very Common (≥1/10) Common (≥1/100 - <1/10) Uncommon (≥1/1,000 - <1/100) Rare (≥1/10,000 - <1/1,000)
Pogosti (≥1/100 do <1/10)
• feeling cold c) The following side effects have been reported in clinical studies in adolescents aged 9 to 17 years.
c) V kliničnih študijah so poročali o naslednjih neželenih učinkih pri mladostnikih, starih od 9 do 17 let.
One pack of 1 single dose pre-filled syringe (type I glass) containing 0.5 ml suspension for injection, with a latex-free plunger stopper (halogeno-butyl rubber) without needles.
Eno pakiranje z 1 enoodmerno napolnjeno injekcijsko brizgo (iz stekla vrste I) z 0,5 ml suspenzije za injiciranje in zamaškom bata brez kavčuka (iz halogenobutilne gume) brez igel.
No case of overdose has been reported for VEPACEL.
Ni poročil o primerih prevelikega odmerjanja cepiva VEPACEL.
The immunological response may be diminished if the patient is undergoing treatment with immunosuppressants.
Če se bolnik zdravi z imunosupresivnimi zdravili, je odziv imunskega sistema lahko manjši.
- If you get any of the side effects, talk to your doctor or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali z medicinsko sestro.
After vaccination the rate of subjects with neutralising antibody titres ≥ 20, seroconversion rate and seroconversion factor as measured by MN assay in immunocompromised subjects and patients with chronic disease conditions were as follows:
Odstotek oseb, ki imajo titer nevtralizirajočih protiteles ≥ 20, ter odstotek serokonverzije in faktor serokonverzije, izmerjeni s testom mikronevtralizacije (MN) po cepljenju preiskovancev, ki so bili imunsko kompromitirani ali pri bolnikov s kroničnimi bolezenskimi stanji, so bili naslednji:
• dry throat
• suho grlo, • bruhanje,
If you get any side effects talk to your doctor or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali z medicinsko sestro.
• rash, hives
• kašelj, • driska,
Clear to opalescent suspension.
Bistra do prekinitve motni.
After vaccination, the rate of subjects with neutralizing antibody titers ≥ 20, seroconversion rate and seroconversion factor, as measured by MN assay, in infants, children, and adolescents aged 6 months to 17 years were as follows:
Odstotek oseb, ki imajo titer nevtralizirajočih protiteles ≥ 20, ter odstotek serokonverzije in faktor serokonverzije, izmerjeni s testom mikronevtralizacije (MN) po cepljenju dojenčkov, otrok in mladostnikov, starih od 6 mesecev do 17 let, so bili naslednji: Test mikronevtralizacije
Multidose vial (10 doses of 0.5 ml per vial)
Večodmerna viala (v viali je 10 odmerkov po 0,5 ml)
Very common (affects more than 1 user in 10):
Zelo pogosti (pojavijo se pri več kot 1 od 10 oseb):
Common (affects 1 to 10 users in 100):
Pogosti (pojavijo se pri 1 do 10 od 100 oseb):
• fits due to fever
• epileptični napadi zaradi zvišane telesne temperature,
History of anaphylactic reactions to the active substance, or to any of the excipients listed in section 6.1, or trace residues (formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein).
navedeno v poglavju 6.1, ali ostanke v sledeh (npr. formaldehid, benzonaza, saharoza, tripsin,
Clinical trials were conducted with the H5N1 vaccine (see section 5.1 for more information on the H5N1 vaccines) in approximately 3700 subjects (ranging in age groups from 18 to 59 years and 60 years and above) and special risk groups of approximately 300 subjects each, consisting of immunocompromised subjects and patients with chronic disease conditions.
Klinična preskušanja s cepivom proti H5N1 (glejte poglavje 5.1 za več informacij o cepivih proti H5N1) so bila opravljena pri približno 3700 preiskovancih (starih od 18 do 59 let in od 60 let naprej)
What VEPACEL is and what it is used for What you need to know before you receive VEPACEL How VEPACEL is given
Kaj morate vedeti, preden boste prejeli cepivo VEPACEL Kako se cepivo VEPACEL daje
These side effects may occur with VEPACEL.
Ti neželeni učinki se lahko pojavijo po cepljenju s cepivom VEPACEL.
Rare (affects 1 to 10 users in 10,000):
Redki (pojavijo se pri 1 do 10 od 10.000 oseb):
• hardness, redness, swelling or bruising at the injection site
• otrdlina, rdečina, oteklina ali podplutba na mestu injiciranja,
STATEMENT OF ACTIVE SUBSTANCE(S) 1 dose (0.5 ml) contains:
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 odmerek (0,5 ml) vsebuje:
There are no post-marketing data available for VEPACEL.
Za cepivo VEPACEL ni na voljo podatkov o spremljanju po pridobitvi dovoljenja za promet.
• neurological disorders such as encephalomyelitis (inflammation of the central nervous system),
Nevrološke motnje, kot so encefalomielitis,
• allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated,
• alergijske reakcije, ki povzročijo nevarno znižanje krvnega tlaka, ki lahko vodi do šoka, če ne ukrepamo; zdravniki poznajo to možnost in imajo pripravljeno nujno zdravljenje za takšne primere,
What VEPACEL contains
Kaj vsebuje cepivo VEPACEL
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
SPLOŠNE TEŽAVE IN SPREMEMBE NA MESTU APLIKACIJE
Influenza virus (whole virion, inactivated), containing antigen of*strain: A/Vietnam/1203/2004 (H5N1) 7.5 micrograms** * produced in Vero cells ** haemagglutinin
A/Vietnam/1203/2004 (H5N1) 7,5 mikrogramov** * pripravljen v celicah Vero
Uncommon (affects 1 to 10 users in 1,000):
Občasni (pojavijo se pri 1 do 10 od 1.000 oseb):
A/Vietnam A/Indonesia A/Vietnam A/Indonesia A/Vietnam A/Indonesia 12 Month Booster 94.1% 93.1% 94.7% 97.2% 100.0% 100.0%
A/Vietnam A/Indonesia A/Vietnam A/Indonesia A/Vietnam A/Indonesia poživitveni odmerek po 12 mesecih
Vomiting Diarrhoea
ŽILNE BOLEZNI
NAME OF THE MEDICINAL PRODUCT VEPACEL suspension for injection in pre-filled syringe Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Cepivo proti prepandemski gripi (H5N1) (s celimi virioni, inaktivirano, pripravljeno v celični kulturi)
2nd Dose
PRILOGA II
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept.
A heterologous booster vaccination with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine has been administered 12 months after a priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in children and adolescents aged 9 to 17 years (N=196), children aged 3 to 8 years (N=79) and infants and children aged 6 months to 35 months (N=25).
Poživitveno cepljenje s 7,5 µg heterolognega cepilnega seva A/Indonesia/05/2005 brez adjuvansa je bilo uporabljeno pri otrocih in mladostnikih, starih od 9 do 17 let (N=196), pri otrocih, starih od 3 do
• pain in the armpit
• bolečine v okončinah,
• stuffy nose
• izcedek iz nosu,
Uncommon (affects 1 to 10 users in 1,000): • generalised skin reactions including urticaria (hives)
Občasni (pojavijo se pri 1 do 10 od 1.000 oseb): • zmanjšan apetit,
METHOD OF ADMINISTRATION Shake before use
POSTOPEK UPORABE Pred uporabo pretresite.
Seroneutralisation rates (MN titre ≥ 20) at 21 days after a 12 months booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains were as follows:
Odstotki seronevtralizacije (titer MN ≥ 20) 21 dni po poživitvenem cepljenju po 12 mesecih s 7,5 µg odmerkom cepiva s sevom A/Indonesia/05/2005, testirani proti homolognemu in heterolognemu sevu,
Ology Bioservices Ireland LTD Wilton Park House Wilton Place
Wilton Park House
Rare: neuralgia, transient thrombocytopenia.
Občasni: generalizirane kožne reakcije Redki: nevralgija, prehodna trombocitopenija.
Malaise
ŽIVČEVJA
What is in this leaflet:
so bili naslednji:
• bruising at the injection site
• zatrdlina na mestu injiciranja
There are no post-marketing surveillance data available for VEPACEL.
• Spremljanje po pridobitvi dovoljenja za promet Za cepivo VEPACEL ni na voljo podatkov o spremljanju po pridobitvi dovoljenja za promet.
Sixteen ferrets were divided into two cohorts and were vaccinated on days 0 and 21 with 7.5 µg of the A/Vietnam/1203/2004 vaccine or were sham vaccinated.
Šestnajst dihurjev je bilo razdeljenih v dve skupini, cepljeni pa so bili na 0. in 21. dan z odmerkom
In a clinical trial 300 adolescents aged 9 to 17 years and 153 children aged 3 to 8 years were administered the H5N1 vaccine.
Otroci in mladostniki, stari od 3 do 17 let: V kliničnem preskušanju je cepivo proti H5N1 prejelo 300 mladostnikov, starih od 9 do 17 let,
However, if this cannot be avoided, the immunoglobulins should not be injected into the same arm used for VEPACEL.
imunoglobulinov ne smete vbrizgati v roko, v katero je bilo dano cepivo VEPACEL.
Arthralgia Myalgia
** hemaglutinina
A booster with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine administered 12 months after a single dose priming vaccination with the A/Vietnam/1203/2004 strain vaccine was also evaluated in adults aged 18 to 59 years.
Odraslim, starim od 18 do 59 let so 12 mesecev po primarnem cepljenju z enim odmerkom cepiva s sevom A/Vietnam/1203/2004 dali heterologno poživitveno cepivo s 7,5 µg formulacijo cepiva s sevom A/Indonesia/05/2005 brez adjuvansa.
The vaccine contains 10 doses of 0.5 ml.
Cepivo vsebuje 10 odmerkov po 0,5 ml. Vsak odmerek po 0,5 ml potegnite v brizgo za injiciranje.
Hypersensitivity reactions, including anaphylaxis, have been reported following use of a similar whole virion, Vero cell derived H1N1 influenza vaccine administered during a pandemic period.
Po uporabi podobnega cepiva proti gripi H1N1 s celimi virioni, razmnoženimi v celicah Vero, v pandemiji so ugotovili preobčutljivostne reakcije, vključno z anafilakso.
Manufacturer
APLIKACIJE
The vaccine should not be administered intravascularly.
Cepiva ne smete injicirati v žilo.
** ≥ 4-fold increase in MN titer *** geometric mean increase
Faktor serokonverzije*** 1,6 * titer MN ≥ 20 ** ≥ 4-kratno povečanje titra MN *** geometrična sredina povečanja
There is no information on the use of VEPACEL under the skin.
Ni podatkov o subkutanem injiciranju cepiva VEPACEL.
Allergic reactions, including sudden life-threatening allergic reactions (anaphylaxis) have been reported following use of a similar vaccine for H1N1 influenza during a pandemic period.
so opisane pri podobnih cepivih proti H1N1 (cepivih proti prašičji gripi), uporabljenih med pandemijo.
• chest discomfort
• splošno slabo počutje,
Sodium chloride Water for injections Polysorbate 80.
- Druge sestavine cepiva so trometamol, natrijev klorid, voda za injekcije, polisorbat 80.
NAME OF THE MEDICINAL PRODUCT VEPACEL
IME ZDRAVILA
NERVOUS SYSTEM DISORDERS
Razvrstitev po organskih sistemih
Children and adolescents aged 3 to 17 years:
in 153 otrok, starih od 3 do 8 let.
Influenza-like illness
OČESNE BOLEZNI
After primary vaccination the rate of subjects with neutralising antibody titres > 20, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in adults aged 18 to 59 years and in older people aged 60 years and above were as follows:
Imunogenost pri odraslih, starih od 18 do 59 let (N=961), in osebah, starih 60 let in več (N=391) Odstotek oseb, ki imajo titer nevtralizirajočih protiteles večji od 20, ter odstotek serokonverzije in faktor serokonverzije, izmerjeni s testom mikronevtralizacije (MN) po prvem cepljenju odraslih,
MN assay
Wilton Place
• hardness, redness, swelling or bruising at the injection site b) The following side effects have been reported in clinical studies in children aged 3 to 8 years.
b) V kliničnih študijah so poročali o naslednjih neželenih učinkih pri otrocih, starih od 3 do 8 let.
Influenza virus (whole virion, inactivated), containing antigen* of strain: A/Vietnam/1203/2004 (H5N1)
Virus gripe (celotni virioni, inaktiviran), ki vsebuje antigen* seva:
Seroneutralization rates (MN titer ≥ 20) at 21 days after a booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains, were as follows:
21 dni po poživitvenem cepljenju s 7,5 µg odmerkom cepiva s sevom A/Indonesia/05/2005, pri čemer je bil uporabljen tako homologen kot tudi heterologen sev cepiva, so bili odstotki seronevtralizacije (titer MN ≥ 20) , naslednji:
Injection site pain Injection site induration Injection site erythema Injection site swelling Injection site hemorrhage
utrujenost pireksija mrzlica splošno slabo počutje gripi podobna bolezen nelagoden občutek v prsnem košu reakcije na mestu injiciranja