natgillin/translations-raw huggingface dataset:
narrow SMQ “Non-infectious encephalitis”
ozko SMQ ”neinfekcijski encefalitis”
Rare: neuralgia, transient thrombocytopenia
Redki: nevralgija, prehodna trombocitopenija
Similarly, the A/lndonesia/05/2005 vaccine was efficacious against a heterologous challenge, showing a vaccine dose-dependent survivorship in the vaccinated cohorts as compared to the control cohort.
Podobno je bilo cepivo A/lndonesia/05/2005 učinkovito pri zaščiti pred heterolognim virusom, saj je bila stopnja preživetja odvisna od odmerka cepiva, injiciranega cepljenim skupinam v primerjavi s kontrolno skupino.
Animal reproductive and developmental toxicity studies with H5N1 strain vaccines (A/Vietnam/1203/2004 and A/Indonesia/05/2005) do not indicate direct or indirect harmful effects with respect to female fertility, pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).
Študije na živalih o vplivu cepiva s sevom H5N1 (A/Vietnam/1203/2004 in A/Indonesia/05/2005) na sposobnost razmnoževanja in razvoj ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost samic, brejost, razvoj zarodka/plodu, kotitev ali postnatalni razvoj (glejte poglavje 5.3).
Allergic reactions, including sudden and life-threatening allergic reactions (anaphylaxis), have been reported with a similar H1N1 influenza vaccine (swine flu vaccine) given during a pandemic period.
Alergijske reakcije, vključno z nenadnimi in smrtno nevarnimi alergijskimi reakcijami (anafilakso), so opisane pri podobnih cepivih proti H1N1 (cepivih proti prašičji gripi), uporabljenih med pandemijo.
The vaccine should never be given into a vein.
Cepivo se ne sme nikoli injicirati v žilo.
Not known (cannot be estimated from the available data)
Neznana (ni mogoče oceniti iz razpoložljivih podatkov) Odrasli in starejše osebe:
The A/Vietnam/1203/2004 vaccine afforded protection against homologous challenge as evidenced by full survivorship, reduced weight loss, a less pronounced and shorter increase in temperature, a less marked reduction in lymphocyte counts and in reduction of inflammation and necrosis in brain and olfactory bulb in the vaccinated cohorts as compared to control animals.
Cepivo A/Vietnam/1203/2004 je zagotovilo zaščito pred homolognim virusom, kar je pokazalo 100-odstotno preživetje živali, manjša izguba teže, manjši in krajši dvig telesne temperature, nižja stopnja zmanjšanja števila limfocitov ter zmanjšanje vnetja in nekroze možganov in olfaktornega bulbusa pri skupini cepljenih živali v primerjavi s kontrolnimi živalmi.
Preferred MedDRA Term
Priporočeni izraz po sistemu MedDRA
The vaccine is available as 1 pack containing 20 multidose vials (type I glass) of 5 ml suspension (10 doses).
Cepivo je na voljo kot eno pakiranje, ki vsebuje 20 večodmernih vial (iz stekla tipa I) s po 5 ml suspenzije (10 odmerkov).
* MN titer ≥ 20
* titer MN ≥ 20
Skin and subcutaneous tissue disorders: angioedema Musculoskeletal and connective tissue disorders: pain in extremity Trivalent seasonal influenza vaccines
Bolezni kože in podkožja: angioedem Bolezni mišično-skeletnega sistema in vezivnega tkiva: bolečine v okončinah
A second dose of vaccine should be given after an interval of at least 3 weeks.
Drugi odmerek cepiva naj bo injiciran po premoru najmanj 3 tednov.
- Rapporteur's assessment report is circulated to CHMP members on Day 50.
- Predaja poročil S-PSUR poročevalcu in članom odbora CHMP bo opravljena na 45. dan. - Poročilo o oceni poročevalca bo posredovano članom odbora CHMP na 50. dan. - Poročilo CHMP bo posredovano izdelovalcu cepiva na 55. dan. - V prvih 6 mesecih bo poročanje potekalo enkrat na mesec.
narrow SMQ “Guillain-Barré syndrome”
ozko SMQ ”Guillain-Barréjev sindrom”
• if you have a bleeding problem or bruise easily.
• če imate težave s krvavitvami oz. strjevanjem krvi ali že pri rahlem udarcu nastanejo modrice.
The other ingredients are: trometamol, sodium chloride, water for injections, polysorbate 80.
Druge sestavine cepiva so: trometamol, natrijev klorid, voda za injekcije, polisorbat 80.
Tell the doctor requesting these tests that you have recently received PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
Povejte zdravniku, ki je naročil te preiskave, da ste bili pred kratkim cepljeni s cepivom PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is and what it is used for What you need to know before you are vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Kaj je cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER in za kaj ga uporabljamo Kaj morate vedeti, preden boste cepljeni s PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
• swelling of tissue just below the skin
• otekanje tkiva pod kožo.
In addition, the immunogenicity has also been evaluated in a Phase 3 study in specified risk groups of immunocompromised subjects (N=122) and patients with chronic disease conditions (N=123) following a 0, 21 day schedule.
Poleg tega so imunogenost ocenjevali tudi v študiji 3. faze pri preiskovancih, ki so bili imunsko kompromitirani (N=122) ali bolnikih s kroničnimi bolezenskimi stanji (N=123) po shemi cepljenja 0.
Frequency of submission
Pogostnost predajanja poročil
Heterologous Booster Vaccinations
Heterologna poživitvena cepljenja
The safety of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER in pregnancy and lactation has not been assessed in clinical trials.
Varnost cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER med nosečnostjo in dojenjem ni bila ovrednotena v kliničnih preskušanjih.
However, if this cannot be avoided, the immunoglobulins should be injected into the other limb.
Če to ni mogoče, je treba imunoglobuline vbrizgati v drugo okončino.
In a second study, sixty-six ferrets were divided into 6 cohorts of 11 ferrets and were immunized on days 0 and 21 with 3.75 µg or 7.5 µg of the Indonesia vaccine or were sham vaccinated.
V drugi študiji je bilo 66 dihurjev razdeljenih na 6 skupin po 11 dihurjev in so bili cepljeni na 0. in 21. dan z odmerkom 3,75 µg ali 7,5 µg cepiva Indonesia ali z lažnim cepivom.
However, if this cannot be avoided, the other vaccine should be injected into the other limb.
Če to ni mogoče, je treba drugo cepivo injicirati v drugo okončino.
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000)
Pogosti (≥1/100 do <1/10) Občasni (≥1/1.000 do <1/100)
The following side effects have been reported in clinical studies in adults and older people.
V kliničnih študijah so poročali o naslednjih neželenih učinkih pri odraslih in starostnikih.
• if you have had any allergic reaction, to any ingredient contained in the vaccine (see section 6 at the end of the leaflet) or to formaldehyde, benzonase or sucrose.
• če ste imeli alergijsko reakcijo na katerokoli sestavino cepiva (glejte poglavje 6 na koncu navodila za uporabo) ali na formaldehid, Benzonazo ali saharozo.
Seroneutralisation rate* * MN titre ≥ 20
Odstotek seronevtralizacije* * titer MN ≥ 20
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
The vaccine should not be administered intravascularly.
Cepivo se ne sme dajati intravaskularno.
Clinical trials were conducted with this H5N1 vaccine (see section 5.1 for more information on the H5N1 vaccines) in approximately 3500 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 tem cepivom proti H5N1 so bila opravljena (glejte poglavje 5.1 za več informacij o cepivih proti H5N1) pri približno 3500 preiskovancih (starih od 18 do 59 let in od 60 let naprej) in v posebnih skupinah s tveganjem pri približno 300 preiskovancih, ki so bili imunsko kompromitirani ali pri bolnikih s kroničnimi bolezenskimi stanji.
• pain in joint or muscle
• bolečine v sklepih ali mišicah,
However, if co-administration with another vaccine is indicated, immunisation should be carried out on separate limbs.
Če pa je hkratno cepljenje z drugimi cepivi indicirano, je treba cepiva injicirati v različni okončini.
• conjunctivitis (an inflammation of the eye), eye irritation
• konjunktivitis (vnetje očesa), draženje oči,
The A/lndonesia/05/2005 vaccine was shown to be efficacious with 100% survival, reduced incidence of fever, reduced weight loss, reduced virus burden, and reduced haematological (leukopenia and lymphopenia) changes in the vaccinated cohorts following homologous challenge.
Ta študija je pokazala, da je cepivo A/lndonesia/05/2005 učinkovito na podlagi 100-odstotnega preživetja živali, manjšega pojava zvišane telesne temperature, manjše izgube telesne mase, zmanjšanega virusnega bremena in manj izraženih hematoloških sprememb (levkopenije in limfopenije) pri cepljenih skupinah, ki jim je bil vbrizgan homologen virus.
Adverse reactions are listed according to the following frequency below.
Neželeni učinki so razvrščeni glede na pogostnost.
narrow SMQ “Vasculitis”
ozko SMQ ”vaskulitis”
The vaccine is an off-white, opalescent, translucent suspension.
Cepivo je sivo bela, opalescentna, prosojna suspenzija.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom ali farmacevtom.
• pain in mouth and throat
• bolečine v ustih in žrelu,
After removing the syringe cap, attach the needle immediately and remove the needle shield prior to administration.
Ko odstranite zaporko brizge, nemudoma namestite iglo.
The following side effects have been reported in clinical studies in adolescents aged 9 to 17 years.
V kliničnih študijah so poročali o naslednjih neželenih učinkih pri mladostnikih, starih od 9 do 17 let.
After first opening, the medicinal product should be used immediately.
Cepivo uporabite nemudoma po prvem odprtju.
INFECTIONS AND INFESTATIONS
INFEKCIJSKE IN PARAZITSKE
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) with or without needles.
Eno pakiranje z 1 enoodmerno napolnjeno injekcijsko brizgo (iz stekla vrste I), ki vsebuje 0,5 ml suspenzije za injiciranje, z zamaškom bata brez lateksa (halogenobutilna guma) z iglami ali brez njih.
In the clinical studies conducted in adults and older people with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER, most side effects were mild in nature and short term.
V kliničnih študijah cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER pri odraslih in starostnikih je bila večina neželenih učinkov blagih in kratkotrajnih.
The vaccine is available or as 1 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) with or without needles.
Cepivo je na voljo kot 1 pakiranje z 1 enoodmerno napolnjeno injekcijsko brizgo (iz stekla tipa I), ki vsebuje 0,5 ml suspenzije za injiciranje z zamaškom bata brez lateksa (halogenobutilna guma) z iglami ali brez.
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is given as an injection into the muscle (usually in the upper arm or upper thigh, depending on the muscle mass).
Zdravnik vam bo cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER dal v obliki injekcije v mišico (po navadi v nadlaket ali zgornji predel stegna, odvisno od mišične mase).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Multidose vial (10 doses of 0.5 ml per vial)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Večodmerna viala (v viali je 10 odmerkov po 0,5 ml)
per 0.5 ml dose * produced in Vero cells ** haemagglutinin
na odmerek 0,5 ml * pripravljen v celicah Vero ** hemaglutinin
In a clinical trial 300 adolescents aged 9 to 17 years and 153 children aged 3 to 8 years were administered the H5N1 vaccine.
V kliničnem preskušanju je cepivo proti H5N1 prejelo 300 mladostnikov, starih od 9 do 17 let, in 153 otrok, starih od 3 do 8 let.
The following side effects have been reported in clinical studies in children aged 3 to 8 years.
V kliničnih študijah so poročali o naslednjih neželenih učinkih pri otrocih, starih od 3 do 8 let.
If it is necessary to provide immediate protection, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be given at the same time as normal or specific immunoglobulin.
Če je to nujno za zagotavljanje takojšnje zaščite, pa je dovoljeno cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER injicirati hkrati s polispecifičnim ali specifičnim imunoglobulinom.
• At the request of the European Medicines Agency.
Posodobljen RMP je treba predložiti: • na zahtevo Evropske agencije za zdravila;
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 10-DOSE VIAL
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - VIALA Z 10 ODMERKI
Some undesirable effects mentioned under section 4.8 such as dizziness and vertigo may affect the ability to drive or use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Na sposobnost vožnje in upravljanja s stroji lahko vplivajo določeni neželeni učinki, ki so navedeni v poglavju 4.8, na primer omotica ali vrtoglavica.
In one study, 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.
V prvi študiji je bilo šestnajst dihurjev razdeljenih v dve skupini, cepljeni pa so bili na 0. in 21. dan z odmerkom 7,5 µg cepiva A/Vietnam/1203/2004 ali z lažnim cepivom.
• dry throat
• zasoplost, • suho grlo,
Two studies have been performed using either the H5N1 A/Vietnam/1203/2004 or the A/Indonesia/05/2005 vaccine.
H5N1 A/Vietnam/1203/2004 in druga s cepivom A/Indonesia/05/2005.
• if you are allergic to any of the ingredients or trace residues (formaldehyde, benzonase, sucrose) contained in the vaccine.
• če ste alergični na katerokoli sestavino ali ostanke v sledeh v cepivu (formaldehid, Benzonaza, saharoza).
The use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be considered during pregnancy if this is thought to be necessary, taking into account official recommendations.
Če je potrebno, se lahko pretehta možnost uporabe cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER med nosečnostjo ob upoštevanju uradnih priporočil.
• vomiting, feeling sick, diarrhoea
• bruhanje, slabost, driska,
Seroprotection rate*
Odstotek serološke zaščite*
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
BOLEZNI DIHAL, PRSNEGA KOŠA IN MEDIASTINALNEGA PROSTORA
Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Cepivo proti pandemski gripi (H5N1) (celi virioni, inaktivirano, pripravljeno v celični kulturi)
Immune system disorders: anaphylactic reaction, hypersensitivity
Bolezni imunskega sistema: anafilaktična reakcija, preobčutljivost Bolezni živčevja: konvulzije
All ferrets were challenged intranasally on day 35 with a high dose of the highly virulent H5N1 virus strain A/Vietnam/1203/2004 and monitored for 14 days.
Vsem dihurjem je bil na 35. dan skozi nos vbrizgan velik odmerek izjemno virulentnega virusa H5N1 seva A/Vietnam/1203/2004, nato pa so bili 14 dni na opazovanju.
Common (affects 1 to 10 in 100 vaccinees):
Pogosti (pojavijo se pri 1 do 10 od 100 oseb):
Ology Bioservices Ireland LTD Wilton Park House Wilton Place
Wilton Park House Wilton Place Dublin 2
Seroneutralisation rate**
seronevtralizacije**
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.
V kliničnem preskušanju je cepivo proti H5N1 prejelo 36 dojenčkov in otrok, starih od 6 do 35 mesecev.
The active substance and other ingredients in PANDEMIC INFLUENZA VACCINE H5N1 BAXTER are listed in section 6 at the end of the leaflet.
Učinkovina in pomožne snovi v cepivu PANDEMIC INFLUENZA VACCINE H5N1 BAXTER so navedene v 6. poglavju na koncu navodil za uporabo.
AESIs will be defined as follows:
Neželeni učinki posebnega pomena bodo opredeljeni takole:
Do not use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER after the expiry date which is stated on the carton.
Cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is an off-white, opalescent, translucent liquid.
Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER je belkasta, opalescentna in prosojna tekočina.
Very common (affects more than 1 in 10 vaccinees):
Zelo pogosti (pojavijo se pri več kot 1 od 10 oseb):
• hardness, redness, swelling or minor bleeding at the injection site
• otrdlina, rdečina, oteklina ali manjša krvavitev na mestu injiciranja,
Cross-reactive immune response against related H5N1 strains In a phase 3 study in adults (N=270) and older subjects (N=272) 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 študiji 3. faze pri odraslih (N=270) in pri starejših osebah (n=272) po cepljenju s cepivom seva A/Vietnam/1203/2004 je bil odstotek oseb z navzkrižnimi nevtralizacijskimi protitelesi, izmerjen z mikronevtralizacijo (titer > 20), naslednji:
• flu-like illness
• gripi podobna bolezen.
GASTROINTESTINAL DISORDERS
Test mikronevtralizacije
After shaking, the vaccine is an off-white, opalescent, translucent suspension.
Ko cepivo pretresete, postane sivo bela, opalescentna, prosojna suspenzija.
** ≥ 4-fold increase in MN titer *** geometric mean increase
* titer MN ≥ 20 ** ≥ 4-kratno povečanje titra MN *** geometrična sredina povečanja
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER suspension for injection Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER suspenzija za injiciranje cepivo proti pandemski gripi (H5N1) (celi virioni, inaktivirano, pripravljeno v celični kulturi)
• Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients and to trace residues e.g. formaldehyde, benzonase, or sucrose.
• Pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaktične reakcije) na zdravilno učinkovino, katerokoli pomožno snov ali ostanke v sledeh, npr. formaldehid, Benzonaza ali saharozo, je treba biti previden.
For PANDEMIC INFLUENZA VACCINE H5N1 BAXTER post-marketing surveillance data are not yet available.
Spremljanje po pridobitvi dovoljenja za promet Za cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER še ni na voljo podatkov o spremljanju po pridobitvi dovoljenja za promet.
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER has been authorised under “exceptional circumstances”.
Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER je pridobilo dovoljenje za promet v ”izjemnih okoliščinah”.
* MN titre ≥ 20
** titer MN ≥ 20
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED SYRINGE
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - NAPOLNJENA INJEKCIJSKA BRIZGA
A 12 to 24 months heterologous booster has also been administered in a phase 3 study in immunocompromised subjects and patients with chronic disease conditions.
Prav tako so v študiji 3. faze preiskovancem, ki so bili imunsko kompromitirani in bolnikom s kroničnimi bolezenskimi stanji, od 12 do 24 meseca dali heterologni poživitveni odmerek.
Common (≥1/100 to <1/10)
Redki (≥1/10.000 do <1/1.000)
The following side effects have been reported in a clinical study in infants aged 6 to 35 months.
V klinični študiji so poročali o naslednjih neželenih učinkih pri dojenčkih, starih od 6 do 35 mesecev.
Nasopharyngitis
MEDIASTINALNEGA
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER 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 PANDEMIC INFLUENZA VACCINE H5N1 BAXTER takes due account of the officially declared pandemic strain.
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER se lahko sprosti v promet šele po uradni razglasitvi SZO/EU pandemije gripe pod pogojem, da imetnik dovoljenja za promet z zdravilom
Infants, children and adolescents from the age of 6 months to 17 years and adults from the age of 18 years and older:
Dojenčki, otroci in mladostniki, stari od 6 mesecev do 17 let, in odrasli od 18. leta starosti naprej: Daje se en odmerek po 0,5 ml.
History of an anaphylactic (i.e. life-threatening) reaction to the active substance, to any of the excipients listed in section 6.1 or to trace residues (e.g. formaldehyde, benzonase, sucrose) of this vaccine.
Anafilaksija v pretekli anamnezi (če je smrtno nevarna) zaradi preobčutljivosti na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali ostanke v sledeh (npr. formaldehid, benzonaza, saharoza).
Adverse Events of Special Interest stratified according to type of report (medically confirmed or non-medically confirmed).
Neželeni učinki posebnega pomena (Adverse Events of Special Interest - AESI), razvrščeni v razrede po vrsti poročila (medicinsko ali nemedicinsko potrjenega).
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
BOLEZNI KOŽE IN PODKOŽJA
20 multidose vials (10 doses per vial - 0.5 ml per dose)
Suspenzija za injiciranje 20 večodmernih vial (10 odmerkov na vialo - 0,5 ml na odmerek)
• irritation or itching at the injection site, bruising or stiff arm
• draženje ali srbenje na mestu injiciranja, modrice ali otrdelost roke,
Seroneutralization rate*
Odstotek seronevtralizacije*
What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is and what it is used for
Kaj je cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER in za kaj ga uporabljamo
- Reporting to be monthly for the first 6 months.
(so)poročevalec v 6-mesečnih časovnih razmikih.
One single dose pre-filled syringe (containing 0.5ml suspension)
Suspenzija za injiciranje Ena enoodmerna napolnjena injekcijska brizga (ki vsebuje 0,5 ml suspenzije)
Contents of the pack and other information What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER contains Active substance:
Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Zdravilna učinkovina:
Insomnia Sleep disorder
PSIHIATRIČNE MOTNJE nespečnost motnje spanja pogosti občasni
Marketing Authorisation Holder: Ology Bioservices Ireland LTD Wilton Park House Wilton Place
Imetnik dovoljenja za promet z zdravilom: Ology Bioservices Ireland LTD
Uncommon (affects 1 to 10 in 1,000 vaccinees):
Občasni (pojavijo se pri 1 do 10 od 1.000 oseb):
After primary vaccination the seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in adults aged 18 to 59 years and in older subjects aged 60 years and above were as follows:
Odstotek serozaščite, odstotek serokonverzije in faktor serokonverzije, izmerjeni z enkratno radialno hemolizo (SRH, single radial haemolysis) za protitelesa proti HA po prvem cepljenju odraslih, starih med 18 in 59 let, ter starejših oseb, starih 60 let in več, so bili naslednji:
• The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
• Če se bolnik zdravi z imunosupresivnimi zdravili, je odziv imunskega sistema lahko manjši.
• malaise,
• nespečnost,
Seroprotection rate* Seroconversion rate** Seroconversion factor***
Odstotek serološke zaščite* Odstotek serokonverzije**
Injections of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER and immunoglobulin should be made into separate limbs.
Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER in imunoglobulin injicirajte v različni okončini.
• pain at the injection site
• bolečina na mestu injiciranja
Whole virion H5N1 influenza vaccine, inactivated, containing antigen of*: A/Vietnam/1203/2004 (H5N1)
cepivo proti gripi H5N1 s celimi virioni, inaktivirano, ki vsebuje antigen*: A/Vietnam/1203/2004 (H5N1)
* SRH area ≥ 25 mm² ** either SRH area ≥ 25 mm if baseline sample negative or 50% increase in SRH area if baseline sample > 4 mm² *** geometric mean increase
* površina SRH ≥ 25 mm² ** bodisi površina SRH ≥ 25 mm² (če je osnovni vzorec negativen) bodisi 50-odstotno povečanje površine
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
SKELETNEGA SISTEMA IN VEZIVNEGA TKIVA
Very common (≥1/10)
Povzetek neželenih učinkov Zelo pogosti (≥1/10)
There is no information on the use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER under the skin.
Ni informacij o injiciranju cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER pod kožo.