natgillin/translations-raw huggingface dataset:
In a consistency study, more than 900 subjects aged 18-60 years received Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg following a 0, 21 days schedule.
V študiji konsistentnosti je Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg po shemi 0. in 21. dan prejelo več kot 900 oseb, starih od 18 do 60 let.
Twenty-one days after the first and second dose of the vaccine, the seroprotection rate, the seroconversion rate and seroconversion factor for anti-haemagglutinin (anti-HA) antibody were as follows:
Enaindvajset dni po cepljenju s prvim in drugim odmerkom cepiva so bili delež serološke zaščite, delež serokonverzije in faktor serokonverzije za antihemaglutininska (anti- HA) protitelesa naslednji:
anti-HA antibody Seroprotection rate*† Seroconversion rate† Seroconversion factor† * anti-HA ≥ 1:40
anti- HA protitelesa Delež serološke zaščite * † Delež serokonverzije † Faktor serokonverzije † * anti- HA ≥ 1: 40
21 days after 1st dose 44.5% 42.5% 4.1
21 dni po
21 days after 2nd dose 94.3% 93.7% 39.8
21 dni po drugem odmerku 94, 3% 93, 7% 39, 8
† seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥ 1:40; seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and have a 4- fold increase in titre; seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
† Delež serološke zaščite: delež oseb s titrom inhibicije hemaglutinacije (IH) ≥ 1: 40; delež serokonverzije: delež oseb, ki so bile pred cepljenjem seronegativne in imajo po cepljenju zaščitni titer ≥ 1: 40, ali so bile pred cepljenjem seropozitivne in imajo 4- kraten porast titra; faktor serokonverzije: razmerje med geometrično sredino (GMS) titra po cepljenju in GMS titra pred cepljenjem.
Twenty-one days after administration of the second dose, 96.0% of subjects had a 4-fold increase in serum neutralising antibody titres.
Enaindvajset dni po cepljenju z drugim odmerkom je 96, 0% oseb imelo 4- krat večji titer nevtralizacijskih protiteles v serumu.
A neutralising antibody titre of at least 1:80 was achieved in 97.8% of subjects at day 42.
42. dan je bil titer nevtralizacijskih protiteles 1: 80 dosežen pri 97, 8% oseb.
5 In a dose finding study in subjects aged 18-60 years, 50 subjects received a dose of 3.75 micrograms HA/ AS03 in a volume of 1 ml at 0 and 21 days.
5 V študiji za določitev odmerka je 50 oseb, starih od 18 do 60 let, prejelo odmerek 3, 75 mikrogramov HA/ AS03 v 1 ml, in sicer na 0. in 21. dan.
The seroprotection rates, seroconversion rates and seroconversion factors for anti-haemagglutinin (anti-HA) antibody at day 42 (post dose 2) and day 180 (persistence) were as follows:
(po prejemu 2. odmerka) in 180. dan (persistenca) so bili naslednji:
Day 42 84% 82% 27.9
42. dan 84% 82% 27, 9
Day 180 54% 52% 4.4
180. dan 54% 52% 4, 4
† seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥ 1:40; seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and have a 4- fold increase in titre; seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
serokonverzije: delež oseb, ki so bile pred cepljenjem seronegativne in imajo po cepljenju zaščitni titer ≥ 1: 40, ali so bile pred cepljenjem seropozitivne in imajo 4- kraten porast titra; faktor serokonverzije: razmerje med geometrično sredino (GMS) titra po cepljenju in GMS titra pred cepljenjem.
A 4-fold increase in serum neutralising antibody titres was observed in 85.7% of subjects at day 42 and 72% at day 180.
42. dan so 4- kraten porast titra nevtralizirajočih protiteles v serumu ugotovili pri 85, 7% oseb, 180. dan pa pri 72% oseb.
Cross-reactive immune response against variants of A/ Vietnam/ 1194/ 2004 (H5N1):
Navzkrižni imunski odziv proti variantam A/ Vietnam/ 1194/ 2004 (H5N1):
In the consistency study the seroprotection rate, seroconversion rate and seroconversion factor for anti- haemagglutinin (anti-HA) antibody against A/ Indonesia/ 5/ 2005 at 21 days after the second dose were as follows:
V študiji konsistentnosti so bili 21 dni po prejemu drugega odmerka delež serološke zaščite, delež serokonverzije in faktor serokonverzije za antihemaglutininska (anti- HA) protitelesa proti A/ Indonesia/ 5/ 2005 naslednji:
anti-HA antibody
anti- HA protitelesa
Seroprotection rate*† Seroconversion rate† Seroconversion factor† * anti-HA ≥ 1:40
Delež serološke zaščite * † Delež serokonverzije † Faktor serokonverzije † * anti- HA ≥ 1: 40
† seroprotection rate: proportion of subjects with haemagglutination
† Delež serološke zaščite: delež oseb s titrom HI ≥ 1: 40; delež serokonverzije: delež oseb, ki so bile pred cepljenjem seronegativne in imajo po cepljenju zaščitni titer ≥ 1: 40, ali so bile pred cepljenjem seropozitivne in imajo 4- kraten porast titra; faktor serokonverzije: razmerje med GMS titra po cepljenju in GMS titra pred cepljenjem.
A 4-fold increase in serum neutralising antibody titres was obtained in 91.4% of subjects at day 42.
42. dan so 4- kraten porast titra nevtralizirajočih protiteles v serumu ugotovili pri 91, 4% oseb.
In the dose finding studythe seroprotection rate, seroconversion rate and seroconversion factor against H5N1 drift variants 21 days after the second dose were as follows:
V študiji za določitev odmerka so bili 21 dni po cepljenju z drugim odmerkom delež serološke zaščite, delež serokonverzije in faktor serokonverzije proti zdrsnim variantam H5N1 naslednji:
† seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥ 1:40; seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and have a 4- fold increase in titre; seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
† Delež serološke zaščite: delež oseb s titrom HI ≥ 1: 40; delež serokonverzije: delež oseb, ki so bile pred cepljenjem seronegativne in imajo po cepljenju zaščitni titer ≥ 1: 40, ali so bile pred cepljenjem seropozitivne in imajo 4- kraten porast titra; faktor serokonverzije: razmerje med GMS titra po cepljenju in GMS titra pred cepljenjem.
6 Twenty one days after the second dose, a 4-fold increase in serum neutralising antibody titres was obtained in 77.1% of subjects against the A/ Indonesia/ 5/ 2005 strain, in 75.0% of subjects against A/ Anhui/ 01/ 2005 and in 85.0% of subjects against A/ Turkey/ Turkey/ 1/ 2005.
Enaindvajset dni po cepljenju z drugim odmerkom so 4- kraten porast titrov nevtralizirajočih protiteles v serumu proti sevu A/ Indonesia/ 5/ 2005 ugotovili pri 77, 1% oseb, proti A/ Anhui/ 01/ 2005 pri 75, 0% oseb in proti A/ Turkey/ Turkey/ 1/ 2005 pri 85, 0% oseb.
Information from non-clinical studies:
6 Podatki iz predkliničnih študij:
In each experiment, four groups of six ferrets were immunized intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/ A/ Vietnam/ 1194/ 04 (NIBRG-14).
V vsakem poskusu so štiri skupine s šestimi živalmi intramuskularno cepili s cepivom, ki je imelo kot adjuvans AS03 in je vsebovalo HA, pridobljen iz H5N1/ A/ Vietnam/ 1194/ 04 (NIBRG- 14).
Doses of 15, 5, 1.7 or 0.6 micrograms of HA were tested in the homologous challenge experiment, and doses of 15, 7.5, 3.8 or 1.75 micrograms of HA were tested in the heterologous challenge experiment.
V homolognem provokacijskem poskusu so raziskovali odmerke 15, 5, 1, 7 ali 0, 6 mikrograma HA, v heterolognem provokacijskem poskusu pa odmerke 15, 7, 5 3, 8 ali 1, 75 mikrograma HA.
Ferrets were vaccinated on days 0 and 21 and challenged by the intra-tracheal route on day 49 with a lethal dose of either H5N1/ A/ Vietnam/ 1194/ 04 or heterologous H5N1/ A/ Indonesia/ 5/ 05.
Dihurje so cepili na 0. in 21. dan, nato pa so 49. dan intratrahealno prejeli letalen odmerek bodisi H5N1/ A/ Vietnam/ 1194/ 04 bodisi heterolognega H5N1/ A/ Indonesia/ 5/ 05.
Of the animals receiving adjuvanted vaccine, 87% and 96% were protected against the lethal homologous or heterologous challenge, respectively.
Od živali, ki so prejele cepivo z adjuvansom, jih je bilo proti smrtni homologni provokaciji zaščitenih 87%, proti heterologni pa 96%.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-foetal and postnatal toxicity (up to the end of the lactation period).
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, akutne toksičnosti in toksičnosti pri ponavljajočih se odmerkih, lokalne tolerance, plodnosti pri samicah, embrio- fetalne in postnatalne toksičnosti (do konca obdobja laktacije) ne kažejo posebnega tveganja za človeka.
Polysorbate 80 Octoxynol 10 Thiomersal Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Magnesium chloride (MgCl2) Water for injections
Viala s suspenzijo: polisorbat 80 oktoksinol 10 tiomersal natrijev klorid (NaCl) natrijev hidrogenfosfat (Na2HPO4) kalijev dihidrogenfosfat (KH2PO4) kalijev klorid (KCl) magnezijev klorid (MgCl2) voda za injekcije
7 6.2 Incompatibilities
7 6. 2 Inkompatibilnosti
After mixing, the vaccine should be used within 24 hours.
18 mesecev Po mešanju morate cepivo uporabiti v 24 urah.
- one pack of 50 vials (type I glass) of 2.5 ml suspension (10 x 0.25 ml doses) with a stopper
- eno pakiranje s 50 vialami (steklo tipa I) po 2, 5 ml suspenzije (10 x 0, 25 ml odmerki) z
(butyl rubber).
zamaškom iz butilne gume.
- two packs of 25 vials (type I glass) of 2.5 ml emulsion (10 x 0.25 ml doses) with a stopper
- dve pakiranji s 25 vialami (steklo tipa I) po 2, 5 ml emulzije (10 x 0, 25 ml odmerki) z zamaškom
(butyl rubber).
iz butilne gume.
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml).
Količina po premešanju 1 viale suspenzije (2, 5 ml) in 1 viale emulzije (2, 5 ml) ustreza 10 odmerkom cepiva (5 ml).
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of two containers:
Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg je na voljo v dveh vsebnikih:
Before mixing the two components, the emulsion and suspension should be allowed to reach room temperature, shaken and inspected visually for any foreign particulate matter and/ or abnormal physical appearance.
Nato ju morate pretresti in pregledati, ali morda vsebujeta tuje delce in/ ali sta nenormalnega videza.
The volume of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg (5 ml) after mixing corresponds to 10 doses of vaccine.
Količina Prepandemičnega cepiva proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg po mešanju (5 ml) ustreza 10 odmerkom cepiva.
Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.
Vsak 0, 5- ml odmerek cepiva izvlecite v injekcijsko brizgo.
GlaxoSmithKline Biologicals s. a. rue de l'Institut 89 B-1330 Rixensart, Belgium
Rue de l' Institut 89 B- 1330 Rixensart, Belgija
KG Zirkustraße 40, D-01069 Dresden Germany
KG Zirkustraße 40, D- 01069 Dresden Nemčija
89, rue de l'Institut B-1330 Rixensart Belgium
89, rue de l' Institut B- 1330 Rixensart Belgija
Pharmacovigilance system 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.
Sistem farmakovigilance 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.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version RMPv4 (dated April 2008) 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.
Načrt za obvladovanje tveganja 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 RMPv4 (april 2008) 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).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je posodobljen načrt za obvladovanje tveganja treba predložiti • ko se pridobijo novi podatki, ki lahko vplivajo na trenutne varnostne specifikacije, načrt farmakovigilance ali aktivnosti za zmanjševanje tveganja. • v 60 dneh po pomembnem novem spoznanju (farmakovigilančnem ali povezanem z zmanjševanjem tveganja). • na zahtevo Evropske agencije za zdravila (EMEA).
11 Outside of the pandemic period, the normal PSUR periodicity and format will be maintained.
11 Periodična poročila o varnosti zdravila (PSUR)
PSUR submission when Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is used during the influenza pandemic:
Predložitev periodičnega poročila o varnosti zdravila pri uporabi Prepandemičnega cepiva proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg med pandemijo gripe:
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.
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.
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 periodic safety update reports with periodicity and format defined as follows:
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 periodična poročila o varnosti zdravila predajati s pogostnostjo in v obliki, kot sledi:
- The clock will start from the first Monday after the date of announcement of the
- Čas začne teči prvi ponedeljek po razglasitvi pandemije gripe (faza 6 načrta SZO o
influenza pandemic (Phase 6 of the WHO Preparedness Plan) (Day 0)
pripravljenosti na gripo) (dan 0).
- Report submission is no later than day 22 (i. e. the following Monday).
- Predaja poročila je najkasneje 22. dan (to je naslednji ponedeljek).
- Serious expected reactions will be reviewed by the MAH as part of their signal
Resne pričakovane neželene učinke bo obravnaval imetnik dovoljenja za promet z zdravilom v sklopu lastnih postopkov ugotavljanja razmerja med koristjo in tveganjem (“ signal detection ”) in bodo vključeni v poročilo le, če se bo stopnja zaskrbljenosti povečala.
- All tables will be based on number of events (presented on PT level, sorted by System
Vse tabele bodo temeljile na številu dogodkov (predstavljenih na PT nivoju, razvrščenih po organskih sistemih) in ne po številu primerov.
- Tables 1 to 4 will be based on events reported from healthcare professionals only.
Tabele od 1 do 4 bodo temeljile le na dogodkih, o katerih so poročali zdravniki.
- In Tables 1 to 5, numbers will be provided for events received during the reporting
V tabelah od 1 do 5 bodo predstavljene številke o dogodkih med obdobjem poročanja in kumulativno.
- All tables will be based on generic and not product-specific data.
Vse tabele bodo temeljile na generičnih podatkih in ne na za zdravilo specifičnih podatkih.
Product-specific
Za zdravilo specifične podatke se lahko ovrednoti med obravnavanjem znakov.
- No line listings are required – these can be provided in signal evaluation reports as
Seznami niso potrebni – ti se po potrebi lahko zagotovijo v poročilih o vrednotenju znakov.
All signal evaluation reports should be provided, including those that were subsequently not identified as being signals.
Skupaj s periodičnim poročilom o varnosti zdravila bo pripravljen tudi kratek povzetek, v katerem je treba izpostaviti vsako področje, ki je vzrok za zaskrbljenost, prioriteto obravnavanja znakov (v primeru več znakov) in zagotoviti ustrezne časovne okvire za predajo popolnega poročila o vrednotenju znaka.
A summary of vaccine distribution shall be included and provide details of the number of doses of vaccine distributed in:
Zagotovljena morajo biti vsa poročila o vrednotenju znakov, tudi tistih, ki kasneje niso bili identificirani kot znaki.
EU member states for the reporting period by batch number, EU member states cumulatively and the rest of the world
Vključen mora biti tudi povzetek o prometu s cepivom, ki mora zagotavljati podrobnosti o številu odmerkov v prometu v: i) državah članicah EU za obdobje poročanja s številko serije, ii) državah članicah EU skupaj in iii) preostalem svetu.
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg suspenzija in emulzija za emulzijo za injiciranje prepandemično cepivo proti gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
Split influenza virus, inactivated, containing antigen equivalent to:
Inaktivirane delce virusa gripe z vsebnostjo antigena *, ki ustreza:
A/ VietNam/ 1194/ 2004 (H5N1) like strain used (NIBRG-14)
3, 75 mikrogramov * A/ VietNam/ 1194/ 2004 (H5N1) podobnemu sevu (NIBRG- 14)
AS03 adjuvant composed of squalene (10.68 milligrams), DL-α -tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams) * haemagglutinin
Adjuvans AS03, ki je sestavljen iz skvalena (10, 68 miligramov), DL- α- tokoferola (11, 86 miligramov) in polisorbata 80 (4, 85 miligramov). * hemaglutinin
Polysorbate 80 Octoxynol 10 Thiomersal Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Magnesium chloride (MgCl2) Water for injections
polisorbat 80 oktoksinol 10 tiomersal natrijev klorid (NaCl) natrijev hidrogenfosfat (Na2HPO4) kalijev dihidrogenfosfat (KH2PO4) kalijev klorid (KCl) magnezijev klorid (MgCl2) voda za injekcije
50 vials: suspension 25 vials x 2: emulsion
50 vial: suspenzija 25 vial x 2: emulzija
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml)
Količina, dobljena z mešanjem 1 viale suspenzije (2, 5 ml) in 1 viale emulzije (2, 5 ml), ustreza 10 odmerkom cepiva (5 ml).
1 dose = 0.5 ml
1 odmerek = 0, 5 ml
Intramuscular use Shake before use Read the package leaflet before use
Pred uporabo preberite priloženo navodilo.
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection Prepandemic influenza vaccine (H5N1)
Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg suspenzija za emulzijo za injiciranje prepandemično cepivo proti gripi (H5N1)
Split influenza virus, inactivated, containing antigen equivalent to A/ VietNam/ 1194/ 2004 (H5N1) like strain used (NIBRG-14) * haemagglutinin
Inaktivirani delci virusa gripe z vsebnostjo antigena, ki ustreza A/ VietNam/ 1194/ 2004 (H5N1) 3, 75 mikrogramov * podobnemu sevu (NIBRG- 14) * hemaglutinin
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
20 PODATKI NA ZUNANJI OVOJNINI
Emulsion for emulsion for injection for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Emulzija za emulzijo za injiciranje za Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg
AS03 adjuvant composed of squalene (10.68 milligrams), DL-α -tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams)
Adjuvans AS03, sestavljen iz skvalena (10, 68 miligramov), DL- α- tokoferola (11, 86 miligramov) in polisorbata 80 (4, 85 miligramov).
22 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SUSPENSION VIAL
22 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH VIALA S SUSPENZIJO
Vial A Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection IM
Viala A Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg suspenzija za emulzijo za injiciranje i. m.
Use within 24 hours and do not store above 25°C.
Uporabite v 24 urah.
10 doses (2.5 ml)
10 odmerkov (2, 5 ml)
23 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS EMULSION VIAL
23 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH VIALA Z EMULZIJO
Vial B Emulsion for emulsion for injection for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg IM
Viala B Emulzija za emulzijo za injiciranje za Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg i. m.
25 PACKAGE LEAFLET:
25 NAVODILO ZA UPORABO
What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is and what it is used for 2.
Kaj je Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg in za kaj ga uporabljamo 2.
Before you receive Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg 3.
Kaj morate vedeti, preden boste cepljeni s Prepandemičnim cepivom proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg 3.
How Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is given 4.
Kako uporabljati Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg 4.
How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg 6.
Shranjevanje Prepandemičnega cepiva proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3, 75 µg 6.