natgillin/translations-raw huggingface dataset:
Fluticasone Furoate GSK was more effective than placebo at reducing symptoms of allergic rhinitis in patients aged six years and over.
Zdravilo Fluticasone Furoate GSK je bilo pri zmanjševanju simptomov alergijskega rinitisa pri bolnikih, starih šest let in več, učinkovitejši od placeba.
In the studies of seasonal allergic rhinitis in adults and adolescents, Fluticasone Furoate GSK reduced symptom scores from a starting point of around 9 points by between 3.6 and 5.4 points over two weeks, compared with a reduction of 2.3 to 3.7 points with placebo.
V študijah sezonskega alergijskega rinitisa pri odraslih in mladostnikih je zdravilo Fluticasone Furoate GSK v dveh tednih za 3, 6 do 5, 4 točke zmanjšalo izhodiščno vrednost simptomov, ki je znašala približno 9 točk, v primerjavi z zmanjšanjem za 2, 3 do 3, 7 točke pri placebu.
In the study of perennial allergic rhinitis, Fluticasone Furoate GSK reduced scores by 3.6 points after four weeks, compared with a reduction of 2.8 points with placebo.
V študiji celoletnega alergijskega rinitisa je zdravilo Fluticasone Furoate GSK po štirih tednih zmanjšalo vrednosti za 3, 6 točke v primerjavi z zmanjšanjem za 2, 8 točke pri placebu.
However, it was not possible to determine if Fluticasone Furoate GSK worked in children below the age of six years, because there were too few children below this age included in the studies.
Ni pa bilo mogoče ugotoviti, ali je zdravilo Fluticasone Furoate GSK delovalo tudi pri otrocih, starih manj kot šest let, ker je bilo v študije vključenih premalo otrok te iz starostne skupine.
What is the risk associated with Fluticasone Furoate GSK?
Kakšna tveganja so povezana z zdravilom Fluticasone Furoate GSK?
The most common side effect with Fluticasone Furoate GSK (seen in more than 1 patient in 10) is epistaxis (nosebleeds).
Najpogostejši neželeni učinek zdravila Fluticasone Furoate GSK (opažen pri več kot 1 bolniku izmed 10) je epistaksa (krvavitev iz nosu).
This is generally mild or moderate and tends to affect adults who have used Fluticasone Furoate GSK for more than six weeks.
Ta je ponavadi blage do zmerne jakosti in je pogostejša pri odraslih, ki zdravilo Fluticasone Furoate GSK uporabljajo več kot šest tednov.
For the full list of all side effects reported with Fluticasone Furoate GSK, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fluticasone Furoate GSK, glejte navodilo za uporabo.
Fluticasone Furoate GSK should not be used in people who are allergic to fluticasone furoate or any of the other ingredients.
Zdravila Fluticasone Furoate GSK ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) flutikazonfuroat ali katero koli drugo sestavino zdravila.
Why has Fluticasone Furoate GSK been approved?
Zakaj je bilo zdravilo Fluticasone Furoate GSK odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that Fluticasone Furoate GSK’ s benefits are greater than its risks for the treatment of the symptoms of allergic rhinitis in patients aged six years or over.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Fluticasone Furoate GSK pri zdravljenju simptomov alergijskega rinitisa pri bolnikih, starih šest let in več, večje od z njim povezanih tveganj.
The Committee recommended that Fluticasone Furoate GSK be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Fluticasone Furoate GSK odobri dovoljenje za promet.
Other information about Fluticasone Furoate GSK:
Druge informacije o zdravilu Fluticasone Furoate GSK:
The European Commission granted a marketing authorisation valid throughout the EU for Fluticasone Furoate GSK to Glaxo Group Ltd. on 6 October 2008.
Evropska komisija je dovoljenje za promet z zdravilom Fluticasone Furoate GSK, veljavno po vsej Evropski uniji, odobrila družbi Glaxo Group Ltd. dne 6. octobra 2008.
The full EPAR for Fluticasone Furoate GSK can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Fluticasone Furoate GSK je na voljo tukaj.
FLUTICASONE FUROATE GSK 27.5 micrograms/ spray nasal spray suspension
FLUTICASONE FUROATE GSK 27, 5 mikrogramov/ vpih pršilo za nos, suspenzija
Fluticasone furoate GSK is indicated for the treatment of: • the symptoms of allergic rhinitis
Zdravilo Fluticasone furoate GSK je indicirano za zdravljenje: • simptomov alergijskega rinitisa.
Hypersensitivity to the active substance or to any of the excipients of Fluticasone furoate GSK.
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov zdravila Flutikazonfuroat GSK.
It may cause irritation of the nasal mucosa.
Zdravilo Fluticasone furoate GSK vsebuje benzalkonijev klorid, ki lahko povzroči draženje nosne sluznice.
Very common > 1/ 10; Common > 1/ 100 to < 1/10; Uncommon > 1/1000 to< 1/100; Rare > 1/10,000 to < 1/ 1000; Very rare < 1/10,000.
Pri razvrstitvi pogostnosti je upoštevan naslednji dogovor: zelo pogosti ≥ 1/ 10, pogosti ≥ 1/ 100 do < 1/ 10, občasni ≥ 1/ 1. 000 do < 1/ 100, redki ≥ 1/ 10. 000 do < 1/ 1. 000 in zelo redki < 1/ 10. 000.
4.9 Overdose
4 4. 9 Preveliko odmerjanje
In a bioavailability study, intranasal doses of up to 2640 micrograms per day were administered over three
V študiji biološke uporabnosti so tri dni uporabljali nazalne odmerke do 2. 640 mikrogramov na dan, pri čemer neželenih sistemskih učinkov niso opazili (glejte poglavje 5. 2).
Seasonal Allergic Rhinitis in adults and adolescents Compared with placebo, fluticasone furoate nasal spray 110 micrograms once daily significantly improved nasal symptoms (comprising rhinorrhoea, nasal congestion, sneezing and nasal itching) and ocular symptoms (comprising itching/ burning, tearing/ watering and redness of the eyes) in all 4 studies.
V primerjavi s placebom je flutikazonfuroat v obliki pršila za nos v odmerku 110 mikrogramov enkrat na dan v vseh 4 študijah pomembno izboljšal nosne simptome (ki so obsegali nosni izcedek, kongestijo nosne sluznice, kihanje in srbenje nosu) in očesne simptome (ki so obsegali srbenje/ pekoč občutek v očeh, solzenje/ izcedek iz oči in rdečino oči).
A study of a single 400 microgram dose of orally inhaled fluticasone furoate in patients with moderate hepatic impairment resulted in increased Cmax (42%) and AUC(0- ∞) (172%) and a modest (on average 23%) decrease in cortisol levels in patients compared to healthy subjects.
V študiji z enim samim 400 mikrogramskim odmerkom peroralno inhaliranega flutikazonfuroata pri bolnikih z zmerno okvaro jeter sta se, v primerjavi z zdravimi osebami, pri bolnikih povečali vrednosti Cmax (42%) in AUC( 0 - ∞) (172%), vrednosti kortizola pa zmerno zmanjšale (v povprečju za 23%).
6 5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti
Fluticasone furoate GSK nasal spray is a predominantly off-white plastic device with a dose indicator window, light blue side actuated lever and lid which contains a stopper.
Steklenička je vstavljena v plastično ohišje, ki je pretežno sive barve.
Glaxo Operations UK, Ltd, (trading as Glaxo Wellcome Operations) Harmire Road Barnard Castle County Durham DL12 8DT
Glaxo Operations UK, Ltd, (pod imenom Glaxo Wellcome Operations) Harmire Road Barnard Castle County Durham DL12 8DT Velika Britanija
The MAH must ensure that the system of pharmacovigilance, as described in version YM2007/ 00033/ 00 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.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici YM2007/ 00033/ 00 v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 04 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.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici 04 načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnih posodobitvah RMP, s katerimi soglaša 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 treba posodobljen načrt za obvladovanje tveganja predložiti: • kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja • v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja) na zahtevo Evropske agencije za zdravila (EMEA).
10 PSURs
10 Redna posodobljena poročila o varnosti zdravila (PSURi)
The PSUR submission cycle based on the International Birth Date (IBD =27 April 2007), until otherwise specified by the CHMP, will be as follows:
2007) in bo potekalo, razen če Odbor za zdravila za uporabo v humani medicini (CHMP) ne bo določil drugače kot sledi:
27 December 2008 PSUR 2:
27.
27 June 2009 PSUR 3:
27.
27 December 2009 PSUR 4:
27.
27 June 2010 PSUR 5:
27.
27 December 2010 PSUR 6:
27.
27 December 2011 PSUR 7:
27.
27 December 2012
2012
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING THE IMMEDIATE PACKAGING >
13 PODATKI NA ZUNANJI OVOJNINI
Fluticasone furoate GSK 27.5 micrograms/ spray nasal spray suspension Fluticasone furoate
Fluticasone furoate GSK 27, 5 mikrogramov/ vpih, pršilo za nos, suspenzija flutikazonfuroat
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
15 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Fluticasone furoate GSK 27.5 micrograms/ spray nasal spray suspension Fluticasone fuorate
Fluticasone furoate GSK 27, 5 mikrogramov/ vpih, pršilo za nos, suspenzija flutikazonfuroat
Fluticasone furoate GSK 27.5 micrograms per spray nasal spray suspension Fluticasone furoate
Fluticasone furoate GSK 27, 5 mikrogramov na vpih, pršilo za nos, suspenzija flutikazonfuroat
What Fluticasone furoate GSK is and what it is used for 2.
Kaj je zdravilo Fluticasone furoate GSK in za kaj ga uporabljamo 2.
Before you use Fluticasone furoate GSK 3.
Kaj morate vedeti, preden boste uporabili zdravilo Fluticasone furoate GSK 3.
How to use Fluticasone furoate GSK 4.
Kako uporabljati zdravilo Fluticasone furoate GSK 4.
How to store Fluticasone furoate GSK 6.
Shranjevanje zdravila Fluticasone furoate GSK 6.
WHAT FLUTICASONE FUROATE GSK IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO FLUTICASONE FUROATE GSK IN ZA KAJ GA UPORABLJAMO
Fluticasone furoate GSK nasal spray is used to treat symptoms of allergic rhinitis including stuffy, runny or itchy nose, sneezing and watery, itchy or red eyes, in adults and children aged 6 years and over.
Fluticasone furoate GSK pršilo za nos uporabljamo pri odraslih in otrocih, starih 6 let in starejših, za zdravljenje simptomov alergijskega rinitisa, vključno z zamašenostjo nosu in izcedkom iz njega, srbenjem nosu, kihanjem, solzenjem in srbenjem ali pordelostjo oči.
Fluticasone furoate GSK belongs to a group of medicines called glucocorticoids.
Zdravilo Fluticasone furoate GSK spada v skupino zdravil, ki jo imenujemo kortikosteroidi.
Fluticasone furoate GSK works to decrease inflammation caused by allergy (rhinitis).
Zdravilo Fluticasone furoate GSK ublaži vnetje, ki je posledica preobčutljivosti (rinitis).
BEFORE YOU USE FLUTICASONE FUROATE GSK
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO FLUTICASONE FUROATE GSK
Do not use Fluticasone furoate GSK:
Ne uporabljajte zdravila Fluticasone furoate GSK:
If you are allergic (hypersensitive) to fluticasone furoate or any of the other ingredients of Fluticasone furoate GSK.
Če ste alergični na (preobčutljivi za) flutikazonfuroat ali katerokoli sestavino zdravila Fluticasone furoate GSK.
Take special care with Fluticasone furoate GSK:
Bodite posebno pozorni pri uporabi zdravila Fluticasone furoate GSK:
Your doctor may adjust your dose of Fluticasone furoate GSK.
Zdravnik bo odmerek zdravila Fluticasone furoate GSK morda prilagodil.
Taking nasal glucocorticoids (such as Fluticasone furoate GSK) for a long time may cause children to grow more slowly.
Zaradi dolgotrajne uporabe kortikosteroidov za nazalno uporabo (zdravila kot je zdravilo Fluticasone furoate GSK) se pri otrocih lahko upočasni rast.
It is especially important to tell your doctor if you are taking, or have recently taken any of the following medicines: • steroid tablets or injected steroids • steroid creams • medicines for asthma • ritonavir, used to treat HIV • ketoconazole, used to treat fungal infections
Še posebej pomembno je, da zdravniku poveste, če jemljete ali ste pred kratkim jemali ali uporabljali katero od naslednjih zdravil: • kortikosteroide za injiciranje ali peroralno uporabo • kortikosteroidne kreme • zdravila za zdravljenje astme
18 Your doctor will assess whether you should take Fluticasone furoate GSK with these medicines.
18 • ritonavir, ki ga uporabljamo pri zdravljenju okužbe z virusom HIV • ketokonazol, ki ga uporabljamo pri zdravljenju glivičnih bolezni
Pregnancy and breast-feeding Do not use Fluticasone furoate GSK if you are pregnant, or planning to become pregnant, unless your doctor or pharmacist tells you to.
Nosečnost in dojenje Če ste noseči ali nameravate zanositi, zdravila Fluticasone furoate GSK ne smete uporabljati, razen če vam tako svetuje zdravnik ali farmacevt.
Do not use Fluticasone furoate GSK if you are breast feeding unless your doctor or pharmacist tells you to.
Če dojite, zdravila Fluticasone furoate GSK ne smete uporabljati, razen če vam tako svetuje zdravnik ali farmacevt.
Driving and using machines Fluticasone furoate GSK is unlikely to affect your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Verjetnost vpliva zdravila Fluticasone furoate GSK na sposobnost upravljanja vozil in strojev je majhna.
In some patients this can cause irritation in the inside of the nose.
Pomembne informacije o nekaterih sestavinah zdravila Fluticasone furoate GSK Zdravilo Fluticasone furoate GSK vsebuje benzalkonijev klorid, ki lahko pri nekaterih bolnikih povzroči draženje nosne sluznice.
HOW TO USE FLUTICASONE FUROATE GSK
KAKO UPORABLJATI ZDRAVILO FLUTICASONE FUROATE GSK
Always use Fluticasone furoate GSK exactly as your doctor has told you.
Pri uporabi zdravila Fluticasone furoate GSK natančno upoštevajte zdravnikova navodila.
When to use it and how much to use Fluticasone furoate GSK is sprayed into the nose as a fine mist.
Kako uporabljati zdravilo Fluticasone furoate GSK in koliko Zdravilo Fluticasone furoate GSK se vpihne v nos v obliki fine meglice.
Fluticasone furoate GSK is not for use in the eyes.
Zdravila Fluticasone furoate GSK ne smete uporabljati na očeh.
When to use Fluticasone furoate GSK • Use once a day • Use at the same time each day.
Kdaj uporabljati zdravilo Fluticasone furoate GSK • Zdravilo uporabljajte enkrat na dan. • Zdravilo uporabljajte vsak dan ob istem času.
How long Fluticasone furoate GSK takes to work Some people will not feel the full effects until several days after first using Fluticasone furoate GSK.
Kdaj se pokažejo učinki zdravljenja z zdravilom Fluticasone furoate GSK Pri nekaterih bolnikih se popolni učinki zdravljenja pokažejo šele več dni po prvi uporabi zdravila Fluticasone furoate GSK.
If you use more Fluticasone furoate GSK than you should Talk to your doctor or pharmacist.
Če ste uporabili večji odmerek zdravila Fluticasone furoate GSK, kot bi smeli Posvetujte se s svojim zdravnikom ali farmacevtom.
If you forget to use Fluticasone furoate GSK • If you miss a dose, take it when you remember. • If it is nearly the time for your next dose, wait until then.
Če ste pozabili uporabiti zdravilo Fluticasone furoate GSK 19 • Če ste pozabili uporabiti odmerek, ga uporabite, ko se spomnite. • Če je že skoraj čas, da uporabite naslednji predvideni odmerek, počakajte in uporabite naslednji odmerek ob običajnem času.
19 How to test the nasal spray before use The nasal spray • Your medicine comes in a glass bottle inside a plastic casing. • The glass bottle contains either 30, 60 or 120 sprays. • A window on the side of the casing allows you to see how much medicine is left.
Preskus pršilnika pred uporabo Pršilo za nos • Zdravilo je na voljo v steklenički, ki se nahaja v plastičnem ohišju. • Vsebina stekleničke zadostuje za 30, 60 ali 120 vpihov. • Okence ob strani ohišja omogoča vpogled v količino preostalega zdravila.
20 Using your nasal spray
20 Uporaba pršilnika
Don ’ t use water to do this, wipe with a clean, dry tissue.
Pri čiščenju ne uporabljajte vode, temveč le čisto, suho krpico.
If you forget to use Fluticasone furoate GSK • If you miss a dose take it when you remember. • If it is nearly the time for your next dose, wait until then.
Če ste pozabili uporabiti zdravilo Fluticasone furoate GSK • Če ste pozabili uporabiti odmerek, ga uporabite, ko se spomnite. • Če je že skoraj čas, da uporabite naslednji predvideni odmerek, počakajte in uporabite naslednji odmerek ob običajnem času.
Like all medicines, Fluticasone furoate GSK can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Fluticasone furoate GSK neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Very common side effects (These can affect more than 1 person in 10) • Nosebleeds (generally minor), particularly if you use Fluticasone furoate GSK for more than 6 weeks continuously.
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 oseb) • Krvavitve iz nosu (običajno blažje), še posebej, če zdravilo Fluticasone furoate GSK uporabljate neprekinjeno dlje kot 6 mesecev.
HOW TO STORE FLUTICASONE FUROATE GSK
SHRANJEVANJE ZDRAVILA FLUTICASONE FUROATE GSK
Do not use Fluticasone furoate GSK after the expiry date which is stated on the label and carton.
Zdravila Fluticasone furoate GSK ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki ali škatli.
Fluticasone furoate GSK nasal spray should be used within 2 months after first opening.
Fluticasone furoate GSK pršilo za nos morate porabiti v 2 mesecih po prvem odprtju.
What Fluticasone furoate GSK contains The active substance is fluticasone furoate.
Kaj vsebuje zdravilo Fluticasone furoate GSK Zdravilna učinkovina je flutikazonfuroat.
What Fluticasone furoate GSK looks like and contents of the pack The medicine is a white nasal spray suspension contained in an amber glass bottle, fitted with a pump.
Izgled zdravila Fluticasone furoate GSK in vsebina pakiranja Pršilo za nos je bela suspenzija v rumenorjavi steklenički, zaprti s pršilnikom.
Fluticasone furoate GSK is available in pack sizes 30, 60 and 120 sprays.
Zdravilo Fluticasone furoate GSK je na voljo v pakiranjih za 30, 60 in 120 vpihov.
22 For information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Glaxo Operations UK, Ltd, (pod imenom Glaxo Wellcome Operations) Harmire Road Barnard Castle County Durham DL12 8DT Velika Britanija
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Če potrebujete več informacij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo zdravila (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali s farmacevtom.
It is a suspension for injection that contains some parts (outer membranes) of the influenza (flu) virus.
Je suspenzija za injiciranje, ki vsebuje nekatere dele (zunanje membrane) virusa influence (gripe).
Focetria is a vaccine that can only be used once a flu ‘ pandemic’ has been officially declared by the World Health Organization (WHO) or European Union (EU).
Zdravilo Focetria je cepivo, ki se lahko uporablja šele potem, ko Svetovna zdravstvena organizacija (WHO) ali Evropska unija (EU) uradno razglasi pandemijo gripe.
A flu pandemic occurs when a new type (strain) of flu virus emerges that can spread easily from person to person because people have no immunity (protection) against it.
Pandemija gripe nastopi, ko se pojavi nova vrsta (sev) virusa gripe, ki se lahko brez težav širi s človeka na človeka, ker ljudje nanj niso imuni (zaščiteni proti njemu).
Focetria would be given according to official recommendations.
Zdravilo Focetria se daje v skladu z uradnimi priporočili.
Focetria is given in two doses, at least three weeks apart.
Zdravilo Focetria se daje v dveh odmerkih v razmaku najmanj treh tednov.
Focetria is a ‘ mock-up’ vaccine.
Zdravilo Focetria je „ modelno “ cepivo.
Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune.
Lahko pa pripravijo cepivo, ki vsebuje posebej izbran sev virusa gripe, ki mu ni bil še nihče izpostavljen in na katerega nihče ni imun.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravno obrambo telesa) „ naučijo “, kako naj se brani pred boleznijo.
When a person is given the vaccine, the immune system recognises the virus as ‘ foreign’ and makes antibodies against it.
Ko oseba prejme cepivo, imunski sistem prepozna virus kot tujek in proti njemu razvije protitelesa.
Focetria contains small amounts of parts of a virus called H5N1.
Cepivo Focetria vsebuje majhne količine delov virusa, imenovanega H5N1.
The virus has been first inactivated (killed) so that it does not cause any disease.
Virus je bil najprej inaktiviran (ubit), tako da ne povzroča bolezni.
The outer membranes that contain the ‘ surface antigens ’ (proteins on the outer membrane of the virus that the body recognises as foreign) have then been extracted and purified.
Zunanje membrane, ki vsebujejo ‘ površinske antigene ’ (beljakovine na zunanji membrani virusa, ki jih telo prepozna kot tuje), so zatem ekstrahirali in prečistili.
The vaccine also contains an ‘ adjuvant ’ (a compound containing oil) to stimulate a better response.
Cepivo vsebuje tudi „ adjuvans “ (spojino, ki vsebuje olje) za stimulacijo boljšega odziva.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Focetria been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged V primeru izbruha pandemije bo sev virusa v zdravilu Focetria nadomeščen s sevom, ki povzroča pandemijo, preden bo cepivo mogoče uporabljati.
The effects of Focetria were first tested in experimental models before being studied in humans.
Učinki zdravila Focetria so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The main study of Focetria included 486 healthy subjects (a third of whom were over the age of 60) and compared the ability of two doses of Focetria to trigger the production of antibodies (immunogenicity).
V njej so primerjali učinkovitost dveh odmerkov cepiva Focetria pri sprožanju nastajanja protiteles (imunogenosti).
The participants received two injections of Focetria, containing either 7.5 or 15 micrograms of haemagglutinin (a protein found in flu viruses), 21 days apart.
Udeleženci so prejeli dve injekciji zdravila Focetria, ki sta vsebovali bodisi 7, 5 ali 15 mikrogramov hemaglutinina (beljakovine, ki se nahaja v virusih gripe) v razmaku 21 dni.
What benefit has Focetria shown during the studies?
Kakšne koristi je zdravilo Focetria izkazalo v raziskavah?