FrancophonIA/ELRC3.0 huggingface dataset:
English: Excipient(s): Methyl parahydroxybenzoate (E 218)
Slovenian: Pomožne snovi: metilparahidroksibenzoat (E 218)
English: Once broached use by:
Slovenian: Načeto zdravilo uporabite do:
English: Dogs: IV Cats: IM
Slovenian: Psi: i.v., i.m Mačke: i.m.
English: In cases of overdose, or if the effects of dexmedetomidine become potentially life- threatening, the appropriate dose of atipamezole is 10 times the initial dose of dexmedetomidine (micrograms/ kg bw or micrograms/ square meter body surface area).
Slovenian: V primeru prevelikega odmerjanja, ali če postanejo učinki deksmedetomidina potencialno nevarni za življenje, je treba uporabiti odmerek atipamezola, ki je 10-krat večji od prvotnega odmerka deksmedetomidina (v mikrogramih/kg telesne mase ali mikrogramih/kvadratni meter telesne površine).
English: INDICATION(S)
Slovenian: KOVIN(E)
English: In cases of overdose, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate antagonist is atipamezole, administered by intramuscular injection, at the following dose: 5 times the initial dose of dexmedetomidine in micrograms/kg bw.
Slovenian: V primeru prevelikega odmerjanja, ali če postanejo učinki deksmedetomidina potencialno nevarni za življenje, je treba uporabiti atipamezol v obliki intramuskularne injekcije v naslednjem odmerku: 5-kratni prvotni odmerek deksmedetomidina v mikrogramih/kg telesne mase.
English: Dogs: IM Cats: IM
Slovenian: Psi: i.m., i.v Mačke: i.m.
English: HE VETER solution for i ydrochloride
Slovenian: A ZA UPOR opina za inji lorid
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one fifth (1/5) of the dose volume of Sedadex 0.1 mg/ml that was given to the dog, regardless of route of administration of Sedadex.
Slovenian: Volumen odmerka atipamezola pri koncentraciji 5 mg/ml ustreza eni petini (1/5) volumna odmerka zdravila Sedadex 0,1 mg/ml, ki je bil dan psu, ne glede na način dajanja zdravila Sedadex.
English: XPIRY DAT month/year} oached use b
Slovenian: TUM IZTEK c/leto} avilo uporabi
English: EATMENT
Slovenian: ETERINAR
English: ONTENTS
Slovenian: OSTORNIN
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.5 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Sedadex 0,5 mg/ml raztopina za injiciranje za pse in mačke deksmedetomidinijev klorid
English: Q 0.5 mg/m
Slovenian: KOL 0,5 mg/ml VSEB
English: Sedadex dexmede
Slovenian: IME Sedadex 0,1
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.1 mg/ml solution for injection for dogs and cats dexmedetomidine hydrochloride
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Sedadex 0,1 mg/ml raztopina za injiciranje za pse in mačke deksmedetomidinijev klorid
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.5 mg/ml solution for injection for dogs and cats
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Sedadex 0,5 mg/ml raztopina za injiciranje za pse in mačke
English: TA Dogs an
Slovenian: OSTI ZDRA
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-half the volume of Sedadex 0.5 mg/ml that was given to the cat.
Slovenian: Volumen odmerka atipamezola pri koncentraciji 5 mg/ml ustreza polovici volumna zdravila Sedadex 0,5 mg/ml, ki je bil dan mački.
English: CKAGE
Slovenian: deksmedeto
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Sedadex 0.1 mg/ml solution for injection for dogs and cats
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Sedadex 0,1 mg/ml raztopina za injiciranje za pse in mačke
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-half (1/2) the volume of Sedadex 0.5 mg/ml that was given to the cat.
Slovenian: Volumen odmerka atipamezola pri koncentraciji 5 mg/ml ustreza eni polovici (1/2) volumna zdravila Sedadex 0,5 mg/ml, ki je bil dan mački.
English: ONLY”
Slovenian: VALI”
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-tenth (1/10) the volume of Sedadex 0.1 mg/ml that was given to the cat.
Slovenian: Volumen odmerka atipamezola pri koncentraciji 5 mg/ml ustreza eni desetini (1/10) volumna zdravila Sedadex 0,1 mg/ml, ki je bil dan mački.
English: BY NUMBE
Slovenian: N DRUGIH
English: NDICATION
Slovenian: INDI
English: by
Slovenian: VILA
English: Dogs: in Cats: int Read the
Slovenian: Psi: intraven Mačke: intr Pred uporab
English: EDICINAL
Slovenian: AVILA
English: ACKAGE S
Slovenian: AŽENA Z M
English: PACKAGE LEAFLET FOR Sedadex 0.5 mg/ml solution for injection for dogs and cats
Slovenian: NAVODILO ZA UPORABO ZA Sedadex 0,5 mg/ml raztopina za injiciranje za pse in mačke
English: S)
Slovenian: E)
English: HT, BY VOL
Slovenian: MASO, PRO
English: PACKAGE LEAFLET FOR Sedadex 0.1 mg/ml solution for injection for dogs and cats
Slovenian: NAVODILO ZA UPORABO ZA Sedadex 0,1 mg/ml raztopina za injiciranje za pse in mačke
English: (equivalent to dexmedetomidine
Slovenian: (ki ustreza 0,08 mg deksmedetomidina).
English: Box 8
Slovenian: Forellenweg 16
English: SARY
Slovenian: INDIKACIJE
English: MUM PARTI ial of 10 ml AME OF TH x 0.1 mg/ml i etomidine hy
Slovenian: VEDBA ZDR e: omidinijev kl 0,08 mg deks
English: AME OF TH x 0.5 mg/ml s etomidine hy
Slovenian: ZDRAVILA 5 mg/ml razt omidinijev kl
English: OD
Slovenian: VILOM OD
English: ARGET SP d cats
Slovenian: RABO V VE iciranje za ps
English: ATCH NUM mber}
Slovenian: RABO V VE
English: TH For anim
Slovenian: AJMANJ N
English: ECIES
Slovenian: NAČ
English: E(S) OF ADM lar use use.
Slovenian: (I) UPORA amuskularna a uporaba navodilo za u
English: BSTANCES
Slovenian: CINI
English: AME OF TH x 0.1 mg/ml s etomidine hy
Slovenian: ZDRAVILA 1 mg/ml razt omidinijev kl
English: IVE AND O
Slovenian: IKACIJA(E
English: WITHDRAWAL PERIOD Not applicable.
Slovenian: Zato uporaba v obdobju brejosti in laktacije ni priporočljiva.
English: Intramuscularly: up to 500 micrograms/square metre body surface area.
Slovenian: Za neinvazivne, blago do zmerno boleče posege in preglede, pri katerih so potrebni mirovanje, sedacija in analgezija: intravensko: do 375 mikrogramov/kvadratni meter telesne površine intramuskularno: do 500 mikrogramov/kvadratni meter telesne površine.
English: SP Read the
Slovenian: EBNA OPO bo preberite n
English: There is no experience in children.
Slovenian: Pri otrocih ni izkušenj.
English: Adults from the age of 18 years:
Slovenian: Odrasli, starejši od 18 let:
English: Vial A
Slovenian: Viala A
English: The symptoms of pandemic flu are similar to those of ordinary flu but are usually more severe.
Slovenian: Simptomi pandemične gripe so podobni simptomom običajne gripe, vendar pa so običajno hujši.
English: It spreads rapidly around the world.
Slovenian: Ta oblika gripe se hitro širi po vsem svetu.
English: Vial B
Slovenian: Viala B
English: • if you are having a blood test to look for evidence of infection with certain viruses.
Slovenian: • če morate opraviti krvne preiskave zaradi testiranja na okužbe z nekaterimi virusi.
English: Pandemic flu is a type of influenza that occurs at intervals that vary from less than 10 years to many decades.
Slovenian: Pandemična gripa je oblika gripe, ki se pojavlja v intervalih od manj kot 10 let do nekaj desetletij.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26/09/2008
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 26/09/2008
English: The vaccine should not usually be given at the same time as other vaccines.
Slovenian: Cepiva se običajno ne sme uporabljati sočasno z drugimi cepivi.
English: These reactions usually disappear within 1-2 days without treatment.
Slovenian: Ti neželeni učinki običajno minejo brez zdravljenja v 1 do 2 dneh.
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Slovenian: • ko se pridobijo novi podatki, ki lahko vplivajo na trenutne varnostne specifikacije, načrt farmakovigilance ali aktivnosti za zmanjševanje tveganja.
English: For further information, see sections 4.4 and 5.1.
Slovenian: Za dodatne informacije glejte poglavji 4.4 in 5.1.
English: 1 dose = 0.5 ml
Slovenian: 1 odmerek = 0,5 ml
English: 3.75 micrograms*
Slovenian: 3,75 mikrogramov*
English: Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or operate machinery.
Slovenian: Nekateri učinki, navedeni v poglavju 4.8, "Neželeni učinki", lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
English: During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Slovenian: Med pandemičnimi razmerami pogostnost predložitve periodičnih poročil o varnosti zdravila, ki je določena v 24. členu Uredbe (ES) št. 726/2004, ne bo zadostovala za spremljanje varnosti pandemičnega cepiva, za katerega se v kratkem časovnem obdobju pričakuje visoka stopnja izpostavljenosti.
English: Allergic reactions, in rare cases leading to shock, have been reported.
Slovenian: Poročali so o pojavu alergijskih reakcij, ki so v redkih primerih vodile v šok.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/478/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/478/001
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Slovenian: V skladu s smernicami Odbora za zdravila za uporabo v humani medicini za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen načrt za obvladovanje tveganja predložen sočasno z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Slovenian: • v 60 dneh po pomembnem novem spoznanju (farmakovigilančnem ali povezanem z zmanjševanjem tveganja).
English: EXP: MM/YYYY
Slovenian: EXP: MM/LLLL
English: Healthcare providers need to assess the benefits and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.
Slovenian: Zdravnik mora presoditi med koristjo in možnimi tveganji pri cepljenju nosečnic in pri tem upoštevati uradna priporočila.
English: Immune response to A/Vietnam/1194/2004 (D42) 71 to 80 years
Slovenian: Imunski odziv proti A/Vietnam/1194/2004 (D42) 71 do 80 let
English: In addition, duration 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.
Slovenian: Poleg tega med trajanjem pandemije, viri, potrebni za poglobljeno vrednotenje periodičnih poročil o varnosti zdravila v obliki, kot je definirana v Pravilih, ki urejajo zdravila v Evropski skupnosti (“Rules Governing Medicinal Product in the European Union” - Volume 9a), morda ne bodo zadostovali za hitro identifikacijo novih varnostnih izsledkov.
English: If you are not sure, talk to your doctor or pharmacist before having this vaccine.
Slovenian: Če niste prepričani, se pred cepljenjem posvetujte z zdravnikom ali s farmacevtom.
English: 25 vials x 2: emulsion
Slovenian: 25 vial x 2: emulzija
English: The vaccine should never be given into a vein or into the skin.
Slovenian: Cepiva se v nobenem primeru ne sme injicirati v žilo ali v kožo.
English: From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have been reported:
Slovenian: Med spremljanjem interpandemičnih trivalentnih cepiv po pridobitvi dovoljenja za promet so poročali o naslednjih neželenih učinkih:
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonic/fetal development, parturition or post-natal development (see section 5.3).
Slovenian: Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na plodnost, nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
English: Uncommon: Generalised skin reactions including urticaria
Slovenian: Občasni: Generalizirane kožne reakcije, vključno z urtikarijo.
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease.
Slovenian: Po cepljenju imunski sistem (naravni obrambni sistem telesa) ustvari lastno zaščito (protitelesa) pred boleznijo.
English: Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.
Slovenian: Vsak 0,5-ml odmerek cepiva izvlecite v injekcijsko brizgo.
English: In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan) and the prepandemic vaccine is used, the MAH shall submit more frequent simplified periodic safety update reports with a format and a periodicity defined in the "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context" (EMEA/49993/2008), and any subsequent update.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zato takoj po razglasitvi pandemije (faza 6 globalnega načrta SZO o pripravljenosti na gripo) in začetku uporabe prepandemičnega cepiva pogosteje predajati redna posodobljena poročila o varnosti zdravila v obliki in s pogostnostjo, kot je opisano v "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context" (EMEA/49993/2008) in vseh nadaljnjih dopolnitvah.
English: Adjuvants are used to improve the body's response to the vaccine.
Slovenian: Adjuvans se uporablja zato, da okrepi telesni imunski odziv na cepivo.
English: Very rare (these may occur with up to 1 in 10,000 doses of the vaccine): • Temporary inflammation of the brain and nerves causing pain, weakness and paralysis that may
Slovenian: Zelo redki (pojavijo se lahko pri do 1 od 10.000 odmerkov cepiva): • Prehodno vnetje možganov in živcev, kar lahko povzroči bolečino, šibkost in ohromelost, ki
English: Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are pregnant or breastfeeding.
Slovenian: Zdravnik mora presoditi o koristih in možnih tveganjih, povezanih s cepljenjem med nosečnostjo ali dojenjem.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Slovenian: Uporaba drugih zdravil ali cepiv Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: There are no data on administration of AS03-adjuvanted vaccines before or following other types of influenza vaccines intended for pre-pandemic or pandemic use.
Slovenian: Na voljo ni podatkov o cepljenju s cepivi z adjuvansom AS03, pred ali po cepljenju z drugimi vrstami cepiv proti gripi, ki so namenjena za prepandemično ali pandemično uporabo.
English: After mixing, the vaccine should be used within 24 hours.
Slovenian: Po mešanju morate cepivo uporabiti v 24 urah.
English: Excipients: It contains 5 micrograms thiomersal
Slovenian: Pomožne snovi: Vsebuje 5 mikrogramov tiomersala.
English: The MAH must ensure that the system of pharmacovigilance, as described in version V03 (dated 19 November 2007) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici V03 (z dne 19. november 2007), predstavljen v modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
English: If you have any further questions on the use of this product, ask your doctor or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom ali z medicinsko sestro.
English: In addition, an updated RMP should be submitted
Slovenian: Poleg tega je posodobljen načrt za obvladovanje tveganja treba predložiti
English: The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180.
Slovenian: Delež serološke zaščite proti A/Indonesia je bil 21 dni po obnovitvenem cepljenju 92% in 180. dan 69,2 %.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version RMPv6 (dated March 2009) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, sprejetem v različici RMPv6 (marec 2009) načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah načrta za obvladovanje tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
English: • Increased sweating, shivering, flu-like symptoms
Slovenian: • močnejše znojenje, drgetanje, gripi podobni simptomi.
English: The vaccine is mixed by withdrawing the contents of the vial containing the emulsion (Vial B) by means of a syringe and by adding it to the vial containing the suspension (Vial A).
Slovenian: Cepivo zmešate tako, da z injekcijsko brizgo izvlečete vsebino viale z emulzijo (Viala B) in jo dodate v vialo s suspenzijo (Viala A).
English: Outside of the pandemic period, the normal PSUR periodicity and format will be maintained.
Slovenian: Izven pandemicnega obdobja se bodo periodicna porocila o varnosti zdravila (PSUR) predajala v obicajni obliki in casovnih obdobjih.
English: A second dose of 0.5 ml should be given after an interval of at least three weeks.
Slovenian: Drugi odmerek 0,5 ml morajo prejeti najmanj 3 tedne po prvem odmerku.
English: Immune response to A/Indonesia/5/2005 0, 6 months schedule 7 days after 2nd dose
Slovenian: Imunski odziv na A/Indonesia/5/2005 shema 0, 6 mesecev 7 dni po drugem odmerku n=47
English: Uncommon (these may occur with up to 1 in 100 doses of the vaccine): • Generalised skin reactions including urticaria (hives)
Slovenian: Občasni (pojavijo se lahko pri do 1 od 100 odmerkov cepiva): • Generalizirane kožne reakcije, vključno z urtikarijo (koprivnico).
English: After mixing, one dose (0.5 ml) contains 3.75 micrograms of haemagglutinin from the following influenza virus strain:
Slovenian: Po premešanju en odmerek (0,5 ml) vsebuje 3,75 mikrogramov hemaglutinina naslednjega seva virusa gripe:
English: The mixed vaccine is a whitish emulsion.
Slovenian: Zmešano cepivo je belkasta emulzija.
English: • Narrowing or blockage of blood vessels with kidney problems
Slovenian: • Zoženje ali zapora krvnih žil z ledvičnimi težavami.
English: Acute severe febrile illness.
Slovenian: Hujša akutna bolezen z zvišano telesno temperaturo.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
English: Clinical studies have evaluated the incidence of adverse reactions listed below in approximately 5,000 subjects 18 years old and above who received formulations containing at least 3.75 microgram HA/AS03.
Slovenian: S kliničnimi študijami so ocenili pojavnost spodaj navedenih neželenih učinkov pri približno 5.000 preiskovancih, starih 18 let in več, ki so prejeli cepiva z vsaj 3,75 mikrograma HA/AS03.
English: After the addition of the emulsion to the suspension, the mixture should be well shaken.
Slovenian: Potem, ko emulzijo dodate suspenziji, morate mešanico dobro pretresti.
English: Suspension for emulsion for injection 50 vials: suspension
Slovenian: Suspenzija za emulzijo za injiciranje 50 vial: suspenzija
English: Neuralgia, convulsions, transient thrombocytopenia.
Slovenian: Nevralgija, konvulzije, prehodna trombocitopenija.
English: Immunisation should be postponed.
Slovenian: V tem primeru je treba cepljenje odložiti.
English: Blood and lymphatic system disorders Common: lymphadenopathy
Slovenian: Bolezni krvi in limfatičnega sistema Pogosti: limfadenopatija
English: Immune response to A/Vietnam/1194/2004 0, 21 days schedule
Slovenian: Imunski odziv proti A/Vietnam/1194/2004 shema 0, 21 dni shema 0, 6 mesecev
English: Split influenza virus inactivated, containing antigen* equivalent to:
Slovenian: Inaktivirane delce virusa gripe z vsebnostjo antigena*, ki ustreza:
English: Very common: headache Uncommon: paraesthesia, somnolence, dizziness
Slovenian: Zelo pogosti: glavobol Občasni: parestezije, somnolenca, omotica
English: Please tell your doctor if you are/may be pregnant or intend to become pregnant, or if you are breast-feeding and follow his advice.
Slovenian: Če ste noseči, mislite, da ste noseči, nameravate zanositi ali dojite to povejte svojemu zdravniku.
English: • Diarrhoea, vomiting, stomach pain, feeling sick
Slovenian: • driska, bruhanje, bolečine v želodcu, siljenje na bruhanje.
English: After two doses administered 6 months apart all subjects had a titre of at least 1:80.
Slovenian: Po dveh odmerkih uporabljenih v razmaku 6 mesecev so vsi preiskovanci imeli titer vsaj 1:80.
English: Vial A: multidose vial containing the antigen (suspension), Vial B: multidose vial containing the adjuvant (emulsion).
Slovenian: Viala A: večodmerna viala z antigenom (suspenzija) Viala B: večodmerna viala z adjuvansom (emulzija)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After mixing, 1 dose (0.5 ml) contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Po premešanju 1 odmerek (0,5 ml) vsebuje:
English: Emulsion for emulsion for injection 25 vials: emulsion
Slovenian: Emulzija za emulzijo za injiciranje 25 vial: emulzija
English: After two doses given 21 days or 6 months apart, 96.0% of subjects had a 4-fold increase in serum neutralising antibody titres and 98-100% had a titre of at least 1:80.
Slovenian: Po dveh odmerkih apliciranih 21 dni ali 6 mesecev narazen je 96,0 % preiskovancev imelo 4-krat večji titer nevtralizacijskih protiteles v serumu in 98-100 % preiskovancev je imelo titer vsaj 1:80.
English: The day 180 seroprotection rates in subjects aged >60 years were 52.9% for those who received two single doses and 69.5% of subjects for those who had received two double doses at day 0 and day 21.
Slovenian: 180. dan je bila serološka zaščita preiskovancev, starejših od 60 let, 52,9%, če so prejeli na dan 0 in 21. dan dva enojna odmerka in 69,5%, če so prejeli dva dvojna odmerka.
English: The suspension is a colourless light opalescent liquid.
Slovenian: Suspenzije je brezbarvna, rahlo opalescentna tekočina.
English: This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1).
Slovenian: Indikacija temelji na podatkih o imunogenosti pri zdravih prostovoljcih, starejšiih od 18 let, po cepljenju z dvema odmerkoma cepiva, pripravljenega iz A/VietNam/1194/2004 NIBRG-14 (H5N1) (glejte poglavje 5.1).
English: A 4-fold increase in serum neutralising antibody titres from day 0 was observed in 85.7% at day 42 and 72% at day 180.
Slovenian: Od dneva 0 so 4-kraten porast titra nevtralizirajočih protiteles v serumu ugotovili 42. dan pri 85,7 % oseb, 180. dan pri 72 % oseb.