FrancophonIA/ELRC3.0 huggingface dataset:
English: The vaccine is available in a multidose container (see section 6.5 for the number of doses per vial).
Slovenian: Cepivo je na voljo v večodmernem vsebniku (število odmerkov na vialo je navedeno v poglavju 6.5).
English: These antigens can be considered as ‘novel' antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Slovenian: Te antigene lahko obravnavamo kot ”nove” antigene, ki posnemajo pogoje, v katerih ciljna populacija še ni bila cepljena.
English: Immunization should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh, depending on the muscle mass.
Slovenian: Cepivo je treba injicirati intramuskularno, v deltoidno mišico ali anterolateralni predel stegna, odvisno od mišične mase.
English: 6 - 35 months
Slovenian: 6-35 mesecev
English: Data obtained with the mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical immunogenicity, safety and reactogenicity data obtained with mock-up vaccines are relevant for the pandemic vaccines.
Slovenian: Podatki, pridobljeni z uporabo modelnega cepiva, bodo uporabljeni pri oblikovanju strategije cepljenja, ki bo najverjetneje uporabljena za cepivo proti pandemski gripi: podatki o klinični imunogenosti, varnosti in reaktogenosti, pridobljeni z modelnimi cepivi,
English: It should be noted that the adverse reactions may be intensified.
Slovenian: Pri tem se lahko okrepijo neželeni učinki.
English: If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER can still be given but your response to the vaccine may be poor.
Slovenian: Če jemljete zdravila, ki zmanjšajo imunost na okužbe, ali prejemate drugo vrsto terapije (radioterapijo), ki vpliva na imunski sistem, boste še vedno lahko cepljeni s cepivom PANDEMIC INFLUENZA VACCINE H5N1 BAXTER, vendar bo lahko vaš odziv na cepivo oslabljen.
English: This section describes the clinical experience with the mock-up vaccine following a two-dose administration.
Slovenian: V tem poglavju so opisane klinične izkušnje pri cepljenju z dvema odmerkoma modelnega cepiva.
English: Product-specific data can be evaluated during signal work-up.
Slovenian: Podatki, specifični za zdravilo, pa bodo lahko ovrednoteni med obdelavo signalov o varnosti.
English: - Guillain-Barré syndrome:
Slovenian: - Guillain-Barréjev sindrom:
English: • insomnia (difficulty sleeping)
Slovenian: • nespečnost (težave pri spanju),
English: 9 - 17 years
Slovenian: 9 - 17 let
English: The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and children during the H1N1 pandemic flu vaccination programme.
Slovenian: 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.
English: Only spontaneously reported data should be included in the S-PSUR.
Slovenian: V poenostavljeno poročilo PSUR morajo biti vključeni le spontano prijavljeni podatki.
English: Immunogenicity in immunocompromised subjects (N=122) and in patients with chronic disease conditions (N=123)
Slovenian: Imunogenost pri preiskovancih, ki so imunsko kompromitirani (N=122) ali bolnikih s kroničnimi bolezenskimi stanji (N=123)
English: Depending on and after implementation of vaccine when first pandemic will take place.
Slovenian: Odvisno od uporabe cepiva ob nastopu prve pandemije in kasneje, po prvi uporabi.
English: The incidence and nature of symptoms after the first and second vaccination were similar to those observed in the healthy adults and older subjects.
Slovenian: Pojavnost in narava simptomov po prvem in drugem odmerku cepiva sta bili podobni kot pri zdravih odraslih in starejših osebah.
English: Ferrets vaccinated with the 7.5 µg dose of the A/Vietnam/1203/2004 vaccine demonstrated a high rate of seroconversion.
Slovenian: Dihurji, cepljeni z odmerkom 7,5 µg cepiva A/Vietnam/ 1203/2004, so pokazali visoko stopnjo serokonverzije.
English: Similar to the homologous challenge, vaccination against a heterologous challenge reduced virus burden, and reduced haematological (leukopenia) changes associated with highly pathogenic avian influenza infection.
Slovenian: Podobno kot pri injiciranju homolognega virusa je tudi pri cepljenju proti heterolognemu virusu prišlo do zmanjšanja virusnega bremena in do manj izraženih hematoloških sprememb (levkopenija), povezanih z izjemno patogeno okužbo s ptičjo gripo.
English: The side-effects are generally similar to those related to the influenza vaccine.
Slovenian: Neželeni učinki so po navadi podobni učinkom, ki jih povzroči cepivo proti gripi.
English: • Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Slovenian: • Pri bolnikih z endogeno ali jatrogeno zmanjšanim imunskim odzivom je protitelesni odziv lahko nezadosten.
English: BLOOD AND LYMPHATIC SYSTEM DISORDERS
Slovenian: BOLEZNI KRVI IN LIMFATIČNEGA SISTEMA
English: The symptoms (signs) of pandemic flu are similar to those of an ‘ordinary' flu but are usually more severe.
Slovenian: Simptomi (znaki) pandemske gripe so podobni znakom ”navadne”
English: The European Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila (EMA) bo vsako leto pregledala vse nove podatke,
English: 21 days after 2nd dose
Slovenian: 21 dni po drugem odmerku
English: • abnormal, reduced sensation
Slovenian: • nenormalno oz. zmanjšano čutenje,
English: If your are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice if you should receive PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, ali ste lahko cepljeni s cepivom PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
English: Animal reproductive and developmental toxicity studies do not indicate direct or indirect harmful effects with respect to female fertility, pregnancy, embryonal/ foetal development parturition or post natal development.
Slovenian: 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.
English: * SRH area ≥ 25 mm²
Slovenian: * površina SRH ≥ 25 mm²
English: Sensory disturbance (paresthesia, dysesthesia, oral dysesthesia, hypoesthesia, dysgeusia, and burning sensation)
Slovenian: glavobol omotica somnolenca nenormalnosti čutil (parestezija, disestezija, oralna disestezija, hipestezija, disgevzija in pekoč občutek)
English: The following serious adverse reactions have been reported from post-marketing surveillance with egg-derived interpandemic trivalent vaccines:
Slovenian: O naslednjih resnih neželenih učinkih so poročali med spremljanjem interpandemskih trivalentnih cepiv, razmnoženih v jajcih, po pridobitvi dovoljenja za promet:
English: 18 - 59 years
Slovenian: 18 - 59 let
English: Male fertility was not investigated in the reproductive and developmental toxicity studies, however there were no findings in the repeat-dose toxicity studies to indicate any vaccine-related changes to the tissues of the male reproductive tract.
Slovenian: Plodnosti samcev v študijah vpliva na sposobnost razmnoževanja in razvoj niso raziskovali, vendar rezultati študij toksičnosti pri ponavljajočih odmerkih ne kažejo s cepivom povezanih sprememb na tkivih moških spolovil.
English: • if you have a poor immune response (for example because of immunosuppressive therapy, e.g. corticosteroid treatments or chemotherapy for cancer);
Slovenian: • če imate oslabljen imunski sistem (na primer zaradi imunosupresivnega zdravljenja z zdravili,
English: In the first few weeks after vaccination with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER the results of these tests may not be correct.
Slovenian: V prvih tednih po cepljenju s cepivom PANDEMIC INFLUENZA VACCINE H5N1 BAXTER izvidi teh preiskav morda ne bodo pravilni.
English: Immunogenicity in adults aged 18 to 59 years (N=961) and in subjects aged 60 years and older (N=391)
Slovenian: in 21. dan. Imunogenost pri odraslih, starih od 18 do 59 let (N=961), in osebah, starih 60 let in več (N=391)
English: • sudden hearing loss, ear pain
Slovenian: • nenadna izguba sluha, bolečine v ušesu,
English: The safety profile in immunocompromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy adults and older subjects.
Slovenian: Varnostni profil pri preiskovancih, ki so imunsko kompromitirani in pri bolnikih s kroničnimi bolezenskimi stanji, je podoben kot pri zdravih odraslih in starejših preiskovancih.
English: The vaccine is available in a single dose pre-filled syringe.
Slovenian: Cepivo je na voljo v enoodmerni napolnjeni injekcijski brizgi
English: narrow SMQ “Non-infectious encephalitis”
Slovenian: ozko SMQ ”neinfekcijski encefalitis”
English: Rare: neuralgia, transient thrombocytopenia
Slovenian: Redki: nevralgija, prehodna trombocitopenija
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: The vaccine should never be given into a vein.
Slovenian: Cepivo se ne sme nikoli injicirati v žilo.
English: Not known (cannot be estimated from the available data)
Slovenian: Neznana (ni mogoče oceniti iz razpoložljivih podatkov) Odrasli in starejše osebe:
English: 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.
Slovenian: 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.
English: Preferred MedDRA Term
Slovenian: Priporočeni izraz po sistemu MedDRA
English: The vaccine is available as 1 pack containing 20 multidose vials (type I glass) of 5 ml suspension (10 doses).
Slovenian: Cepivo je na voljo kot eno pakiranje, ki vsebuje 20 večodmernih vial (iz stekla tipa I) s po 5 ml suspenzije (10 odmerkov).
English: * MN titer ≥ 20
Slovenian: * titer MN ≥ 20
English: Skin and subcutaneous tissue disorders: angioedema Musculoskeletal and connective tissue disorders: pain in extremity Trivalent seasonal influenza vaccines
Slovenian: Bolezni kože in podkožja: angioedem Bolezni mišično-skeletnega sistema in vezivnega tkiva: bolečine v okončinah
English: A second dose of vaccine should be given after an interval of at least 3 weeks.
Slovenian: Drugi odmerek cepiva naj bo injiciran po premoru najmanj 3 tednov.
English: - Rapporteur's assessment report is circulated to CHMP members on Day 50.
Slovenian: - 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.
English: narrow SMQ “Guillain-Barré syndrome”
Slovenian: ozko SMQ ”Guillain-Barréjev sindrom”
English: • if you have a bleeding problem or bruise easily.
Slovenian: • če imate težave s krvavitvami oz. strjevanjem krvi ali že pri rahlem udarcu nastanejo modrice.
English: The other ingredients are: trometamol, sodium chloride, water for injections, polysorbate 80.
Slovenian: Druge sestavine cepiva so: trometamol, natrijev klorid, voda za injekcije, polisorbat 80.
English: Tell the doctor requesting these tests that you have recently received PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
Slovenian: Povejte zdravniku, ki je naročil te preiskave, da ste bili pred kratkim cepljeni s cepivom PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
English: Trometamol, sodium chloride, water for injections, polysorbate 80
Slovenian: trometamol, natrijev klorid, voda za injekcije, polisorbat 80
English: 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
Slovenian: 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
English: • swelling of tissue just below the skin
Slovenian: • otekanje tkiva pod kožo.
English: 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.
Slovenian: 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.
English: Frequency of submission
Slovenian: Pogostnost predajanja poročil
English: Heterologous Booster Vaccinations
Slovenian: Heterologna poživitvena cepljenja
English: The safety of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER in pregnancy and lactation has not been assessed in clinical trials.
Slovenian: Varnost cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER med nosečnostjo in dojenjem ni bila ovrednotena v kliničnih preskušanjih.
English: However, if this cannot be avoided, the immunoglobulins should be injected into the other limb.
Slovenian: Če to ni mogoče, je treba imunoglobuline vbrizgati v drugo okončino.
English: 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.
Slovenian: 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.
English: However, if this cannot be avoided, the other vaccine should be injected into the other limb.
Slovenian: Če to ni mogoče, je treba drugo cepivo injicirati v drugo okončino.
English: 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)
Slovenian: Pogosti (≥1/100 do <1/10) Občasni (≥1/1.000 do <1/100)
English: The following side effects have been reported in clinical studies in adults and older people.
Slovenian: V kliničnih študijah so poročali o naslednjih neželenih učinkih pri odraslih in starostnikih.
English: • 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.
Slovenian: • če ste imeli alergijsko reakcijo na katerokoli sestavino cepiva (glejte poglavje 6 na koncu navodila za uporabo) ali na formaldehid, Benzonazo ali saharozo.
English: Seroneutralisation rate* * MN titre ≥ 20
Slovenian: Odstotek seronevtralizacije* * titer MN ≥ 20
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: The vaccine should not be administered intravascularly.
Slovenian: Cepivo se ne sme dajati intravaskularno.
English: 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.
Slovenian: 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.
English: • pain in joint or muscle
Slovenian: • bolečine v sklepih ali mišicah,
English: However, if co-administration with another vaccine is indicated, immunisation should be carried out on separate limbs.
Slovenian: Če pa je hkratno cepljenje z drugimi cepivi indicirano, je treba cepiva injicirati v različni okončini.
English: • conjunctivitis (an inflammation of the eye), eye irritation
Slovenian: • konjunktivitis (vnetje očesa), draženje oči,
English: 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.
Slovenian: 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.
English: Adverse reactions are listed according to the following frequency below.
Slovenian: Neželeni učinki so razvrščeni glede na pogostnost.
English: narrow SMQ “Vasculitis”
Slovenian: ozko SMQ ”vaskulitis”
English: MARKETING AUTHORISATION NUMBER EU/1/09/571/002
Slovenian: EU/1/09/571/002
English: The vaccine is an off-white, opalescent, translucent suspension.
Slovenian: Cepivo je sivo bela, opalescentna, prosojna suspenzija.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom ali farmacevtom.
English: • pain in mouth and throat
Slovenian: • bolečine v ustih in žrelu,
English: After removing the syringe cap, attach the needle immediately and remove the needle shield prior to administration.
Slovenian: Ko odstranite zaporko brizge, nemudoma namestite iglo.
English: The following side effects have been reported in clinical studies in adolescents aged 9 to 17 years.
Slovenian: V kliničnih študijah so poročali o naslednjih neželenih učinkih pri mladostnikih, starih od 9 do 17 let.
English: After first opening, the medicinal product should be used immediately.
Slovenian: Cepivo uporabite nemudoma po prvem odprtju.
English: INFECTIONS AND INFESTATIONS
Slovenian: INFEKCIJSKE IN PARAZITSKE
English: 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.
Slovenian: 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.
English: 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.
Slovenian: V kliničnih študijah cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER pri odraslih in starostnikih je bila večina neželenih učinkov blagih in kratkotrajnih.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Multidose vial (10 doses of 0.5 ml per vial)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Večodmerna viala (v viali je 10 odmerkov po 0,5 ml)
English: per 0.5 ml dose * produced in Vero cells ** haemagglutinin
Slovenian: na odmerek 0,5 ml * pripravljen v celicah Vero ** hemaglutinin
English: In a clinical trial 300 adolescents aged 9 to 17 years and 153 children aged 3 to 8 years were administered the H5N1 vaccine.
Slovenian: 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.
English: The following side effects have been reported in clinical studies in children aged 3 to 8 years.
Slovenian: V kliničnih študijah so poročali o naslednjih neželenih učinkih pri otrocih, starih od 3 do 8 let.
English: 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.
Slovenian: Če je to nujno za zagotavljanje takojšnje zaščite, pa je dovoljeno cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER injicirati hkrati s polispecifičnim ali specifičnim imunoglobulinom.
English: • At the request of the European Medicines Agency.
Slovenian: Posodobljen RMP je treba predložiti: • na zahtevo Evropske agencije za zdravila;
English: MARKETING AUTHORISATION NUMBER EU/1/09/571/001
Slovenian: EU/1/09/571/001
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 10-DOSE VIAL
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - VIALA Z 10 ODMERKI
English: Some undesirable effects mentioned under section 4.8 such as dizziness and vertigo may affect the ability to drive or use machines.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • dry throat
Slovenian: • zasoplost, • suho grlo,
English: Two studies have been performed using either the H5N1 A/Vietnam/1203/2004 or the A/Indonesia/05/2005 vaccine.
Slovenian: H5N1 A/Vietnam/1203/2004 in druga s cepivom A/Indonesia/05/2005.