natgillin/translations-raw huggingface dataset:
These antigens can be considered as ‘ novel’ antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Ti antigeni delujejo kot "novi" antigeni in posnemajo stanje, pri katerem ciljna populacija še ni bila cepljena.
The seroprotection rate* seroconversion rate* and the seroconversion factor ** for anti-HA antibody in the adults measured by SRH were as follows:
Stopnja serološke zaščite *, stopnja serološke konverzije * in faktor serološke konverzije, izmerjeni s SRH za protitelesa proti HA, so bili pri odraslih naslednji:
The seroprotection rate* seroconversion rate* and the seroconversion factor ** for anti-HA antibody in subjects aged over 60 measured by SRH were as follows:
Stopnja serološke zaščite *, stopnja serološke konverzije * in faktor serološke konverzije ** izmerjeni s SRH za protitelesa proti HA, so bili pri starejših od 60 let naslednji:
Two doses of vaccine containing H9N2 (A/ chicken/ Hong Kong/ G9/ 97) strain at 4 different dosages (3.75, 7.5, 15 and 30 µg HA/ dose), were administered four weeks apart.
17 V presledku 4 tednov so pri 4 različnih odmerkih (3, 75; 7, 5; 15 in 30 μg HA/ odmerek) uporabili dva odmerka cepiva, ki je vsebovalo sev H9N2 (A/ Chicken/ Hong Kong/ G9/ 97).
17 Focetria has been authorised under “ Exceptional Circumstances”.
Zdravilo Focetria je pridobilo dovoljenje za promet v "izjemnih okoliščinah".
Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Sodium citrate, Citric acid, Thiomersal, Water for injections.
Natrijev klorid Kalijev klorid Kalijev dihidrogenfosfat Dinatrijev fosfat dihidrat Magnezijev klorid heksahidrat Kalcijev klorid dihidrat Natrijev citrat Citronska kislina Tiomersal Voda za injekcije.
5.0 ml in 10-dose vial (type I glass) with stopper (halo-butyl rubber).
5, 0 ml v viali z desetimi odmerki (steklo vrste I) z zamaškom (halobutilna guma).
The vaccine should be allowed to reach room temperature before use.
18 Cepivo mora pred uporabo doseči sobno temperaturo.
MARKETING AUTHORISATION HOLDER 18 Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, Italy.
Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, Italija.
(Manufacturer responsible for monovalent pooled harvests, before final filtration):
(Izdelovalec, odgovoren za monovalentne zbrane pridelke, pred končnim filtriranjem):
(Manufacturer responsible for final filtration of monovalent pooled harvest):
(Izdelovalec, odgovoren za končno filtriranje monovalentnih zbranih pridelkov):
Bellaria – 53018 Rosia – Sociville (SI) Italy
Bellaria – 53018 Rosia – Sociville (SI) Italija
Focetria 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 Focetria takes due account of the officially declared pandemic strain.
Cepivo Focetria se lahko trži samo, kadar SZO/ EU uradno razglasi pandemijo gripe, pod pogojem, da imetnik dovoljenja za promet s cepivom Focetria upošteva uradno razglašen pandemični sev.
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance vzpostavljen in delojoč, preden začne tržiti zdravilo in ves čas uporabe zdravila na trgu.
PSUR submission during the influenza pandemic:
Predložitev PSUR med pandemijo gripe:
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.
Med pandemijo pogostnost predložitve periodičnih poročil o varnosti (periodic safety update reports – PSUR), ki je določena v 24. členu predpisa (ES) št.
Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
726/ 2004, ne bo ustrezna za varnostni nadzor cepiva proti pandemični okužbi, pri katerem se pričakuje visoka raven izpostavljenosti v kratkem časovnem obdobju.
21 vaccinated.
V takšnih primerih je potrebno hitro poročanje o varnostnih informacijah, ki so lahko pri pandemiji izjemno pomembne za razmerje med 21 tveganjem in koristjo.
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 pandemijo morda resursi, potrebni za poglobljeno oceno periodičnih poročil o varnosti v obliki, kakršno določa Zvezek 9a pravil, ki urejajo zdravila v Evropski skupnosti, ne bodo na voljo, da bi z njimi hitro identificirali varnostna vprašanja.
In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan) and the pandemic vaccine is used, the MAH shall submit periodic safety update reports with periodicity and format defined as follows:
Zato mora imetnik dovoljenja za promet z zdravilom takoj po razglasitvi pandemije (6. faza globalnega načrta SZO za pripravljenost na gripo) in po začetku uporabe pandemičnega cepiva, predložiti periodična poročila o varnosti v naslednjih presledkih in v naslednji obliki:
Frequency of submission
Pogostost predložitve
- The clock will start from the first Monday after shipment of the first batch of vaccine.
- Čas se začne meriti prvi ponedeljek po dostavi prve serije cepiva.
- First data-lock point is 14 days later.
- Prvo zaključeno obdobje zbiranja podatkov je 14 dni pozneje.
- Report submission is no later than day 22 (i. e. the following Monday).
- Predložitev poročila je najkasneje na 22. dan (tj. naslednji ponedeljek).
- Reporting to be fortnightly for the first 3 months of the pandemic.
- Prve tri mesece pandemije je poročanje vsakih 14 dni.
- Periodicity will be reviewed by the MAH and the (Co-)Rapporteur at 3 monthly intervals.
- Imetnik dovoljenja za promet z zdravilom in (so -) poročevalec bosta ocenila periodičnost v
Format The report shall include the following Tables of aggregate data using the agreed templates:
trimesečnih presledkih.
Fatal and/ or life-threatening reactions – for each Preferred Term (PT), including the proportion of fatal reports
1.
2.
Fatalne in/ ali smrtno nevarne reakcije za vsak prednostni izraz (PI), vključno z deležem poročil o smrti 2.
3.
Neželeni učinki posebnega interesa (PI) 3.
4.
Resne nepričakovane reakcije (PI) 4.
Adverse Events of Special Interest (PTs) Serious unexpected reactions (PTs) All events occurring in the following age groups:
Vsi dogodki v naslednjih starostnih skupinah:
6-23 months, 2-8 years, 8-17 years, 18-60 years, > 60 years All events occurring in pregnant women
Vsi dogodki pri nosečnicah 5.
6.
Vsi dogodki, o katerih poročajo bolniki, ki niso bili vneseni v zbirko podatkov do zaključenega obdobja zbiranja podatkov 6.
All events reported by patients that have been entered into the database by data-lock point A cumulative overview of all events reported during the period, stratified according to type of reporter (patient or health care professional), seriousness, expectedness, and whether spontaneous or solicited.
Zbirni pregled vseh dogodkov, o katerih so poročali v tem obdobju (bolniki ali zdravniki), njihova resnost, pričakovanost in podatek o tem, ali so bila poročila spontana ali spodbujena.
Presentation of data will take into consideration the following recommendations:
Pri predstavitvi podatkov je treba upoštevati naslednja priporočila:
- Serious expected reactions will be reviewed by the MAH as part of their signal detection procedures
Resne pričakovane reakcije bo pregledal imetnik dovoljenja za promet z zdravilom, kot del postopkov za odkrivanje signalov in bodo le del poročila, če se pojavi razlog za skrb.
and will only form part of the report if an issue of concern arises.
-
- All tables will be based on number of events (presented on PT level, sorted by System Organ Class
Vse tabele bodo zasnovane na številu dogodkov (prikazanih na ravni PI, razvrščenih po organskem sistemu [OS]), ne pa na številu primerov.
[SOC]) and not number of cases.
- -
- Tables 1 to 4 will be based on events reported from healthcare professionals only.
Tabele od 1 do 4 bodo zasnovane na dogodkih, o katerih so poročali samo zdravniki.
- In Tables 1 to 5, numbers will be provided for events received during the reporting period and
V tabelah od 1 do 5 bo prikazano število dogodkov, prejetih med obdobjem poročanja in kumulativno število.
cumulatively.
-
- All tables will be based on generic and not product-specific data.
Vse tabele bodo zasnovane na generičnih podatkih, ne pa na podatkih za specifična zdravila.
Product-specific data can be
Podatki za specifična zdravila se lahko ocenijo med prvo obdelavo signalov.
evaluated during signal work-up.
-
- No line listings are required – these can be provided in signal evaluation reports as necessary.
Seznam po alineah ni nujen – ti podatki so lahko po potrebi prikazani v poročilih za ocenjevanje signalov.
A short summary shall also be provided with the periodic safety update reports, in which any area of concern should be highlighted, signal work-up prioritised (in the event of multiple signals) and appropriate timelines for submission of a full signal evaluation report provided.
K poročilom o varnosti je treba predložiti kratek povzetek, v katerem so poudarjeni kakršni koli razlogi za zaskrbljenost, obdelava signalov razvrščena po prioriteti (če je več signalov) in ki vsebuje ustrezen razpored za celotno oceno signalov.
All signal evaluation reports should be provided, including those that were subsequently not identified as being signals.
Predložena morajo biti vsa poročila o oceni signalov, vključno s poročili o dogodkih, ki pozneje niso bili identificirani kot signali.
A summary of vaccine distribution shall be included and provide details of the number of doses of vaccine distributed in:
Poročilo mora vsebovati povzetek distribucije cepiva in podrobnosti o številu odmerkov, porazdeljenih v:
EU member states for the reporting period by batch number, EU member states cumulatively and the rest of the world
državah članicah EU, po številki serije za obdobje poročanja, državah članicah EU kumulativno in ostalih državah.
22 The MAH commits to performing the studies and pharmacovigilance activities detailed in the Pharmacovigilance Plan.
22 Načrt za obvladovanje tveganja
An updated Risk Management Plan should be provided as per the CHMP Guideline on Risk Management Systems for medicinal products for human use.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in dejavnosti, povezane s farmakovigilanco, opisane v načrtu farmakovigilance.
C.
< C.
Depending on and after implementation of vaccine when first pandemic will take place.
Odvisno od in po uporabi cepiva v primeru prve pandemije.
During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan.
Med pandemijo bo predlagatelj opravil prospektivno kohortno študijo, kot je opredeljeno v načrtu farmakovigilance.
Focetria suspension for injection in pre-filled syringe Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Cepivo proti pandemični gripi (površinski antigeni, inaktivirani, z adjuvansom).
One dose (0.5 ml) contains:
En odmerek (0, 5 ml) vsebuje:
Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in eggs, and adjuvanted with MF59C.1, of strain:
Zdravilne učinkovine: površinski antigeni (hemaglutinin in nevraminidaza), razmnoženi v jajcih, z dodanim adjuvansom MF59C. 1, seva:
7.5 micrograms haemagglutinin
7, 5 mikrogramov hemaglutinina
MF59C.1 oil in water emulsion containing squalene, as 80 and sorbitan trioleate in a citrate buffer.
MF59C. 1 emulzija olja v vodi, ki vsebuje skvalen kot oljno polisorbatom 80 in sorbitantrioleatom v citratnem pufru.
the oil phase, stabilised with polysorbate
fazo, stabilizirana s
Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, water for injections.
Natrijev klorid, kalijev klorid, kalijev dihidrogenfosfat, dinatrijev fosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat, natrijev citrat, citronska kislina voda za injekcije.
1 x single dose (0.5 ml) pre-filled syringe 10 x single dose (0.5 ml) pre-filled syringes
1 napolnjena injekcijska brizga z enkratnim odmerkom (0, 5 ml) 10 napolnjenih injekcijskih brizg z enkratnim odmerkom (0, 5 ml)
Do not inject intravascularly or subcutaneously.
Ne injicirajte intravaskularno ali subkutano.
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
27 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
CARDBOARD BOX FOR 1-DOSE VIAL
OZNAKA ZA BRIZGO
Focetria suspension for injection Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Cepivo proti pandemični gripi (površinski antigen, inaktiviran, z adjuvansom) i. m. injiciranje v deltoidno mišico.
STATEMENT OF ACTIVE SUBSTANCE(S)
Pred uporabo nežno pretresite.
One dose (0.5 ml) contains:
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Active Ingredients:
En odmerek (0, 5 ml) vsebuje:
MF59C.1 oil in water emulsion containing squalene, as 80 and sorbitan trioleate in a citrate buffer.
MF59C. 1 emulzija olja v vodi, ki vsebuje skvalen kot oljno fazo, stabilizirana s polisorbatom 80 in sorbitantrioleatom v citratnem pufru.
Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, water for injections.
Natrijev klorid, kalijev klorid, kalijev dihidrogenfosfat, dinatrijev fosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat, natrijev citrat, citronska kislina, voda za injekcije.
Vial 10 x 1 dose 1 dose (0.5 ml)
Viala 10 x 1 odmerek 1 odmerek (0, 5 ml)
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
30 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
CARDBOARD BOX FOR 10-DOSE VIAL
OZNAKA ZA VIALO Z ENIM ODMERKOM
Focetria suspension for injection in multidose container Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Cepivo proti pandemični gripi (površinski antigen, inaktiviran, z adjuvansom) i. m. injiciranje v deltoidno mišico.
Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, thiomersal, water for injections.
Natrijev klorid, kalijev klorid, kalijev dihidrogenfosfat, dinatrijev fosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat, natrijev citrat, citronska kislina tiomersal, voda za injekcije.
Vial 10 x 10 doses 1 dose (0.5 ml)
Viala 10 x 10 odmerkov 1 odmerek (0, 5 ml)
31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
33 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
METHOD OF ADMINISTRATION
OZNAKA ZA VIALO Z DESETIMI ODMERKI
1 dose (0.5 ml)
1.
Novartis V & D S. r. l. - Italy Store in a refrigerator.
IME ZDRAVILA IN POT( I) UPORABE
LABEL FOR 10-DOSE VIAL
Focetria injekcija
Focetria injection Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted) I. M. injection into the deltoid muscle
Cepivo proti pandemični gripi (površinski antigen, inaktiviran, z adjuvansom) i. m. injiciranje v deltoidno mišico.
EXP.:
Upor.
5 ml vial containing 10 doses (0.5 ml/ dose)
5- mililitrska viala, ki vsebuje 10 odmerkov (0, 5 ml/ odmerek)
Novartis V & D S. r. l. - Italy Store in a refrigerator.
Novartis V & D S. r. l. - Italija Shranjujte v hladilniku.
Focetria suspension for injection in pre-filled syringe Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Cepivo proti pandemični gripi (površinski antigen, inaktiviran, z adjuvansom)
Read all of this leaflet carefully before you start receiving this medicine.
Pred uporabo natančno preberite navodilo.
tell your doctor.
omenjen v tem navodilu, obvestite svojega zdravnika.
What Focetria is and what it is used for 2.
Kaj je zdravilo Focetria in za kaj ga uporabljamo 2.
Before you receive Focetria 3.
Kaj morate vedeti, preden boste prejeli zdravilo Focetria 3.
How to receive Focetria 4.
Kako uporabljati zdravilo Focetria 4.
How to store Focetria 6.
Shranjevanje zdravila Focetria 6.
WHAT FOCETRIA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO FOCETRIA IN ZA KAJ GA UPORABLJAMO
Focetria is a vaccine against a pandemic influenza (flu).
Zdravilo Focetria je cepivo proti pandemični gripi.
It has to be used for the prophylaxis of influenza in an officially declared pandemic situation.
Uporablja se za preprečevanje gripe pri uradno razglašeni pandemiji.
The vaccine works by causing the body to produce its own protection (antibodies) against the disease
Cepivo deluje tako, da spodbudi lastno zaščito telesa (nastanek protiteles) proti bolezni.
BEFORE YOU RECEIVE FOCETRIA
KAJ MORATE VEDETI, PREDEN BOSTE PREJELI ZDRAVILO FOCETRIA
Do not take Focetria if you:
Ne jemljite zdravila Focetria, če:
- have experienced serious allergic reaction (i. e. life-threatening) to any of the constituents of Focetria,
- imate resne (npr. smrtno nevarne) alergijske reakcije na katerokoli sestavino zdravila Focetria,
- are allergic (hypersensitive) to influenza vaccines or any of the ingredients of Focetria,
- ste alergični na (preobčutljivi za) cepiva proti gripi ali katerokoli sestavino zdravila Focetria,
- are allergic to eggs, chicken protein,
- ste alergični na jajca, piščančje beljakovine,
- are allergic to any antibiotic, formaldehyde, cetyltrimethylammonium bromide (CTAB) and
- ste alergični na katerikoli antibiotik, formaldehid, cetiltrimetilamonijev bromid (CTAB) in
polysorbate 80.
polisorbat 80
Take special care with Focetria if you:
Bodite posebno pozorni pri uporabi zdravila Focetria, če:
- feel feverish,
- imate zvišano telesno temperaturo,
- have any illness or infection,
- imate katero koli bolezen ali okužbo,
- are having immunosuppressive therapy, e. g. corticosteroid treatment or chemotherapy for cancer, or if
- prejemate imunosupresivno zdravljenje, npr. kortikosteroide ali kemoterapijo proti raku, ali če
you have any condition which makes you prone to infections (immunodeficiency conditions), In any of these cases, TELL YOUR DOCTOR, as vaccination may not be recommended, or may need to be delayed.
imate kakršno koli bolezen, zaradi katere ste dovzetni za okužbe (pomanjkanje imunosti), V katerem koli od teh primerov POVEJTE ZDRAVNIKU, ker cepljenje morda ni priporočeno ali pa ga je treba opraviti pozneje.
Focetria should not be given at the same time as other vaccines (if another vaccine is required at the same time, then the injection should be carried out on a different limb.
Zdravilo Focetria se ne sme dajati sočasno z drugimi cepivi (če je sočasno cepljenje z drugim cepivom nujno, ga je treba injicirati v drugo okončino.
Pregnancy and breast-feeding In a severe pandemic situation, the administration of the vaccine is recommended in pregnant women, irrespective of their stage of pregnancy.
Nosečnost in dojenje Pri hudi pandemiji je uporaba cepiva pri nosečnicah priporočena, ne glede na stopnjo nosečnosti.
Driving and using machines The vaccine is unlikely to produce any effect on the ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi cepivo imelo vpliv na sposobnost upravljanja vozil in strojev.
35 3.
36 3.
HOW TO RECEIVE FOCETRIA
KAKO UPORABLJATI ZDRAVILO FOCETRIA
Your doctor or nurse administers the vaccine.
Cepivo vam bo dal zdravnik ali medicinska sestra.
A dose (0.5 ml) of the vaccine will be injected into the upper arm (deltoid muscle).
Odmerek (0, 5 ml) cepiva vam bodo injicirali v zgornji del roke (deltoidno mišico).
Like all medicines, Focetria can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Focetria neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Common (in more than 1 out of 100 people, but less than 1 in 10).
Pogosti (pri več kot 1 osebi od 100, vendar manj kot 1 od 10).
Common side effects include: redness, swelling, pain at the site of injection, bruising, hardening of the skin injection site.
Pogosti neželeni učinki so: rdečica, otekanje, bolečina na mestu injiciranja, modrice, otrditev kože na mestu injiciranja.
(in more than 1 out of 1,000 people, but less than 1 in 100).
Občasni (pri več kot 1 osebi od 1000, vendar manj kot 1 od 100).
Uncommon side effects may include: generalised skin reactions including itching, bumps on the skin or a non-specific rash.
Občasni neželeni učinki so lahko: splošne kožne reakcije, kot so srbenje, bule na koži ali neznačilni izpuščaj.
Rare (in more than 1 out of 10,000 people, but less than 1 in 1,000).
Redki (pri več kot 1 osebi od 10. 000, vendar manj kot 1 od 1. 000).
Rare side effects include: numbness or tingling sensations, involuntary muscle contractions or transient thrombocytopenia (a low platelet count in the blood which can result in bleeding or bruising).
Redki neželeni učinki so: občutek otrplosti ali mravljinčenja, nenadzorovano krčenje mišic ali prehodna trombocitopenija (zmanjšano število trombocitov v krvi, kar lahko povzroči krvavitve ali modrice).
Very rare (in less than 1 in 10,000).
Zelo redki (pri manj kot 1 osebi od 10. 000).
Very rare side effects include: vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems) and exudative Stevens-Johnson syndrome (erythema multiforme).
Zelo redki neželeni učinki so: vaskulitis (vnetje krvnih žil, ki lahko povzroči kožne izpuščaje, bolečine v sklepih in težave z ledvicami) in eksudativni Stevens - Johnsonov sindrom (multiformni eritem).
Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome.
Nevrološke motnje, kot so encefalomielitis (vnetje osrednjega živčevja), nevritis (vnetje živcev) in vrsta paralize, znana kot Guillain- Barréjev sindrom.
HOW TO STORE FOCETRIA
SHRANJEVANJE ZDRAVILA FOCETRIA
Do not use Focetria after the expiry date which is stated on the carton and the label after EXP.
Zdravila Focetria ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in ovojnini poleg oznake "Uporabno do/ Upor. do".
Medicines should not be disposed of via wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali gospodinjske odpadke.
What Focetria contains
37 Kaj vsebuje zdravilo Focetria
- Active Substance:
- Zdravilna učinkovina:
36 Focetria does not contain live virus particles and so it cannot cause Pandemic influenza.
Zdravilo Focetria ne vsebuje živih virusnih delcev, zato ne more povzročiti pandemične gripe.
They are isolated from the surface of influenza virus particles, which are grown in hen’ s eggs and inactivated with formaldehyde.
Izolirani sta iz delcev plašča virusa gripe, ki jih gojijo v piščančjih jajcih in ki so inaktivirani s formaldehidom.
These viral proteins are prepared from the strain of influenza virus that complies with the WHO recommendations and EU decision in an officially declared Pandemic situation.
Virusne beljakovine so pripravljene iz seva virusa gripe, ki je skladen s priporočili SZO in odločbo EU pri uradno razglašeni pandemiji.
One dose (0.5 ml) of the vaccine contains at least 7.5 micrograms of haemagglutinin from the following recommended influenza virus strain:
En odmerek (0, 5 ml) cepiva vsebuje vsaj 7, 5 mikrogramov hemaglutinina iz naslednjih priporočenih sevov virusa gripe:
The vaccine contains an ‘ adjuvant’ (a compound containing squalene) to stimulate a better response.
Cepivo vsebuje "adjuvans" (spojino, ki vsebuje skvalen) za spodbujanje boljšega odziva.
- Other Ingredients:
- Pomožne snovi: