natgillin/translations-raw huggingface dataset:
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer's disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
V klinični študiji, ki podpira vlogo za pridobitev dovoljenja za promet, pri skupini 252 bolnikov z zmerno do hudo Alzheimerjevo boleznijo (3-14 točk na lestvici KPSS ("Kratkem preskusu spoznavnih sposobnosti" oz. MMSE ali "Mini-mental State Examination") ob vključitvi je zdravljenje z memantinom v monoterapiji pokazalo izboljšanje v primerjavi s placebom, v obdobju 6 mesečnega zdravljenja (analiza opazovanih bolnikov, lestvice CIBIC-plus - ("Clinician's Interview-Based Impression of Change Plus Caregiver Input" oz. "Vtis sprememb na osnovi kliničnega intervjuja"): p=0,025; ADCS-ADLsev ("Alzheimer's Disease Consortium Studies Activities of Daily Livingmodified for severe dementia" oz. "Vprašalnik vsakodnevnih aktivnosti"): p=0,003; SIB ("Severe Impairment Battery" oz. "Baterije za hudo prizadetost"): p=0,002).
Tablet coat for 10/20 mg film-coated tablets: Hypromellose
Obloga tablete pri 10/20 mg filmsko obloženih tabletah: hipromeloza makrogol 400 titanov dioksid
In patients with moderate renal impairment (creatinine clearance 3049 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations).
Pri bolnikih z zmerno okvaro delovanja ledvic (očistek kreatinina 30 - 49 ml/min) naj bo dnevni odmerek 10 mg (1 ml raztopine, kar ustreza dvema pritiskoma navzdol).Če bolnik zdravljenje dobro prenaša, se lahko odmerek po najmanj 7 dneh zdravljenja zviša do 20 mg dnevno, po standardni titracijski shemi.
Memantine hydrochloride Week 1, Day 1 2 3 4 5 6 7 7 Film-coated tablets Ebixa 5 mg
Ebixa 5 mg memantinijev klorid Teden 1, Dan 1 2 3 4 5 6 7
Four pump actuations
PODATKI NA ZUNANJI OVOJNINI
Small white particles may be present.
Morda so prisotni majhni beli delci.
107.0±0.5 FFU***
107,0±0,5 FFE***
The vaccine targets three strains of influenza virus each year, following the annual recommendations by the World Health Organisation.
Cepivo vsako leto cilja na tri seve virusa gripe v skladu z vsakoletnimi priporočili Svetovne zdravstvene organizacije.
The use of FLUENZ should be based on official recommendations.
Uporaba cepiva FLUENZ mora temeljiti na uradnih priporočilih.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 January 2011
Datum prve odobritve: 27. januarja 2011
(See also, How Fluenz is given, in section 3).
(Glejte tudi Kako se aplicira cepivo Fluenz, poglavje 3).
Adverse reaction frequencies are reported as: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Very rare (< 1/10,000)
Pogostnosti neželenih učinkov so poročane kot: zelo pogosti (≥1/10) pogosti (≥1/100 do <1/10) občasni (≥1/1.000 do <1/100) zelo redki (<1/10.000)
.......................................................................................................per 0.2 ml dose
.......................................................................................................na 0,2 ml odmerek
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation)
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
The vaccine is unlikely to have an effect on the ability to drive and use machines.
Cepivo najverjetneje ne vpliva na sposobnost vožnje ali uporabe strojev.
• if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicine, or other treatment.
• če vam je vaš zdravnik povedal, da imate oslabljen imunski sistem kot posledico bolezni, zdravila, ki ga jemljete ali drugega načina zdravljenja.
All strains regardless of match
Vsi sevi neodvisno od ujemanja
Name and address of the manufacturers of the biological active substance(s)
Ime in naslov izdelovalcev biološke zdravilne učinkovine (učinkovin)
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Vaccine recipients should attempt to avoid, whenever possible, close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination.
Prejemniki cepiva morajo, kjer je to mogoče, preprečiti tesen stik s hudo imunsko oslabljenimi osebami (npr. prejemniki kostnega mozga, ki po presaditvi potrebujejo izolacijo) še 1-2 tedna po cepljenju.
• if you are under 18 years of age and already taking acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever).
• če ste stari manj kot 18 let in že jemljete acetilsalicilno kislino (snov, prisotna v številnih zdravilih za lajšanje bolečin in nižanje povišane telesne temperature).
FLUENZ should not be administered to children and adolescents with severe asthma or active wheezing because these individuals have not been adequately studied in clinical studies.
Cepiva FLUENZ se ne sme uporabiti pri otrocih in mladostnikih s hudo astmo ali aktivnim sopenjem, saj te osebe niso bile ustrezno preučene v kliničnih študijah.
• if you are allergic to eggs, egg proteins, gentamicin, or gelatin or any of the other ingredients of Fluenz (listed in section 6 “Contents of the pack and other information”).
• če ste alergični na jajca, jajčne beljakovine, gentamicin, na želatino ali katero koli sestavino cepiva Fluenz (navedeno v poglavju 6 ”Vsebina pakiranja in dodatne informacije”).
What you need to know before you are given Fluenz
Kaj morate vedeti, preden boste prejeli cepivo Fluenz
It is used in children and adolescents 24 months to less than 18 years of age.
Uporablja se za otroke in mladostnike stare od 24 mesecev in manj kot 18 let.
FLUENZ has been administered to over 30,000 individuals in controlled clinical studies over multiple years, in various regions and using different vaccine strains.
Cepivo FLUENZ je prejelo več kot 30.000 oseb v kontroliranih kliničnih študijah v obdobju več let, v različnih regijah in z uporabo različnih sevov cepiva.
What Fluenz is and what it is used for
Kaj je cepivo Fluenz in za kaj ga uporabljamo
Follow your doctor, nurse or pharmacist's instructions about when your child should return for the second dose.
Upoštevajte navodila zdravnika, medicinske sestre ali farmacevta glede tega, kdaj naj se otrok vrne po drugi odmerek.
• Do not give acetylsalicylic acid to children aged less than 18 years for 4 weeks after vaccination with Fluenz unless your doctor, nurse or pharmacist tells you otherwise.
• Otrokom starim manj kot 18 let ne dajajte acetilsalicilne kisline še 4 tedne po cepljenju s cepivom Fluenz, razen če vam zdravnik, medicinska sestra ali farmacevt ne naročijo nasprotno.
In studies of adults in which a high percentage of individuals had underlying chronic medical conditions, the safety profile of FLUENZ was comparable to the safety profile observed in individuals without these conditions.
V študijah z odraslimi, kjer je imel velik odstotek oseb obstoječo kronično bolezen, je bil varnostni profil cepiva FLUENZ primerljiv z varnostnim profilom, ki so ga opazili pri osebah brez teh bolezni.
• DO NOT USE WITH A NEEDLE.
• Ne uporabljajte z iglo.
Prophylaxis of influenza in individuals 24 months to less than 18 years of age.
Preprečevanje gripe pri osebah starih od 24 mesecev do manj kot 18 let.
The following information is intended for medical or healthcare professionals only: Fluenz is for nasal use only.
Navodila za zdravstveno osebje Naslednje informacije so namenjene samo zdravstvenemu osebju: Cepivo Fluenz je samo za nazalno uporabo.
Like all medicines, Fluenz can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi cepivo Fluenz neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The influenza virus strains in FLUENZ are (a) cold-adapted (ca); (b) temperature-sensitive (ts); and (c) attenuated (att).
Sevi virusa gripe v cepivu FLUENZ so (a) hladno-prilagojeni (cold-adapted, ca); (b) občutljivi na temperaturo (temperature-sensitive, ts); in (c) oslabljeni (attenuated, att).
Your doctor, nurse or pharmacist will decide if Fluenz can be given at the same time as other vaccines.
Vaš zdravnik, medicinska sestra ali farmacevt se bo odločil, ali lahko prejmete cepivo Fluenz sočasno z drugimi cepivi.
Fluenz vaccine viruses are grown in chicken eggs.
Virusi za cepiva Fluenz proti gripi se vzgajajo v piščančjih jajcih.
He or she will decide if Fluenz is suitable for you.
Odločil/-a se bo, ali je cepivo Fluenz za vas primerno.
B/Massachusetts/2/2012-like strain (B/Massachusetts/2/2012, MEDI 237751)
B/Massachusetts/2/2012-podoben sev (B/Massachusetts/2/2012, MEDI 237751)
FLUENZ's efficacy data in the paediatric population consist of 9 controlled studies comprising over 20,000 infants and toddlers, children and adolescents, conducted during 7 influenza seasons.
Podatki o učinkovitosti cepiva FLUENZ v pediatrični populaciji so sestavljeni iz 9 kontroliranih študij, ki so zajele več kot 20.000 dojenčkov in malčkov, otrok in mladostnikov in so se izvajale v 7 sezonah gripe.
11 to 24 M 1,150 2002-2003 78.4%
11 do 24 m 1.150 2002-2003 78,4%
Region Age Range a
Regija Starostni razpon a
Therefore, as some viruses are excreted in human milk, FLUENZ should not be used during breastfeeding.
Ker se nekateri virusi izločajo v materino mleko, se cepiva FLUENZ med dojenjem ne sme uporabljati.
Vaccine recipients should be informed that FLUENZ is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts.
Prejemnike cepiva je treba obvestiti, da je cepivo FLUENZ cepivo z oslabljenim živim virusom in ima potencial za prenos na imunsko oslabljene osebe.
Fluenz is a trademark of MedImmune, LLC.
Fluenz je blagovna znamka družbe MedImmune, LLC.
Additional experience has occurred with marketed use of this vaccine.
V času trženja cepiva so se pridobile dodatne izkušnje.
• If you are pregnant, think you may be pregnant, plan to become pregnant soon or are breast feeding, tell your doctor, nurse or pharmacist before receiving this vaccine.
• če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev ali če dojite, se posvetujte s svojim zdravnikom, medicinsko sestro ali farmacevtom, preden prejmete to cepivo.
Fluenz is not recommended for women who are pregnant or are breast-feeding.
Cepiva Fluenz se ne priporoča pri nosečnicah ali ženskah, ki dojijo.
MARKETING AUTHORISATION NUMBER(S) EU/1/10/661/002 < - 10 sprayers>
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/661/002 <10 pršilnikov >
There have been occasional reports of administration of twice the recommended dose of FLUENZ in the post-marketing setting.
Obstajajo občasna poročila o uporabi dvakratnega priporočenega odmerka cepiva FLUENZ v obdobju po začetku trženja.
Pack size of 10.
Pakiranje z 10 nosniki.
M = months b Reduction in culture-confirmed influenza illness relative to placebo.
e a m = meseci b Zmanjšanje obolelosti za gripo, potrjene s kulturo, glede na placebo.
• Fluenz is administered as a divided dose in both nostrils as described below.
• Cepivo Fluenz se aplicira kot razdeljen odmerek v obe nosnici kot je opisano spodaj.
While animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, FLUENZ is not recommended during pregnancy.
Čeprav študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja, cepiva FLUENZ ne uporabljajte pri nosečnicah.
However, based upon the potential for influenza antiviral agents to reduce the effectiveness of FLUENZ, it is recommended not to administer the vaccine until 48 hours after the cessation of influenza antiviral therapy.
Vendar pa se zaradi potenciala protivirusnih zdravil proti gripi za zmanjšanje učinkovitosti cepiva FLUENZ ne priporoča uporaba cepiva do 48 ur po končanem protivirusnem zdravljenju proti gripi.
Before use, the vaccine may be taken out of the refrigerator, without being replaced, for a maximum period of 12 hours at a temperature not above 25°C.
Pred uporabo lahko cepivo vzamete iz hladilnika za največ 12 ur pri temperaturi do 25 °C, vendar ga potem ne smete več hraniti v hladilniku.
What Fluenz is and what it is used for What you need to know before you are given Fluenz How Fluenz is given
Kaj je cepivo Fluenz in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli cepivo Fluenz Kako uporabljati cepivo Fluenz Možni neželeni učinki
However, a conclusion on clinical benefit of this vaccine in adults could not be made given that results observed in some studies versus injectable influenza vaccines were suggestive of a lower efficacy of FLUENZ.
Vendar pa sklepanja o kliničnih koristih tega cepiva pri odraslih niso mogoča, ker kažejo rezultati nekaterih študij, kjer so cepivo primerjali s cepivi proti gripi, ki se injicirajo, manjšo učinkovitost cepiva FLUENZ.
The co-administration of FLUENZ with inactivated vaccines has not been studied.
Sočasne uporabe cepiva FLUENZ z inaktiviranimi cepivi niso preučevali.
As with most vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of FLUENZ.
Kot pri vseh cepivih je treba nemudoma zagotoviti ustrezno obliko zdravljenja in zdravniškega nadzora v primeru anafilaktične reakcije po uporabi cepiva FLUENZ.
USA 15 to 71 M 1,259
ZDA 15 do 71 m 1.259
MedImmune, LLC 297 North Bernardo Avenue, Moutain View
MedImmune, LLC 297 North Bernardo Avenue, Mountain View
A/Victoria/361/2011 (H3N2)-like strain (A/Texas/50/2012, MEDI 237514)
A/Victoria/361/2011 (H3N2)-podoben sev (A/Texas/50/2012, MEDI 237514)
FLUENZ is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
Uporaba cepiva FLUENZ ni kontraindicirana pri osebah z asimptomatsko okužbo z virusom HIV; ali osebah, ki prejemajo lokalne/inhalacijske kortikosteroide ali nizkoodmerne sistemske kortikosteroide ter pri tistih, ki prejemajo kortikosteroide kot nadomestno zdravljenje, npr. pri insuficienci nadledvične žleze.
If the vaccine has not been used after this 12-hour period, it should be disposed of.
Če ga ne porabite v 12 urah, ga morate zavreči.
Do not use Fluenz after the expiry date which is stated on the applicator label after the letters EXP.
Cepiva Fluenz ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki nosnika poleg črk EXP.
• The recommended dose for children and adolescents is 0.2 ml Fluenz, administered as 0.1 ml in each nostril.
• Priporočeni odmerek je tako za otroke kot za mladostnike 0,2 ml cepiva Fluenz, danega po 0,1 ml v vsako nosnico.
Safety data regarding use of FLUENZ have been compiled from over 28,500 children and adolescents 2 to 17 years of age from clinical studies and over 52,500 children and adolescents from post-authorisation safety studies.
Varnostne podatke o uporabi cepiva FLUENZ so zbrali v kliničnih študijah od več kot 28.500 otrocih in mladostnikih starih od 2 do 17 let in v varnostnih študijah po začetku trženja od več kot 52.500 otrocih in mladostnikih.
e The primary circulating strain was antigenically dissimilar from the H3N2 strain represented in the vaccine; efficacy against the mismatched A/H3N2 strain was 85.9% (95% CI: 75.3, 91.9).
e Primarni sev, ki je krožil, je bil antigensko različen od seva H3N2 v cepivu; učinkovitost proti neujemajočem se sevu A/H3N2 je bila 85,9% (95-% IZ: 75,3; 91,9).
FLUENZ should under no circumstances be injected.
Cepiva FLUENZ se ne sme v nobenem primeru injicirati.
The concurrent use of FLUENZ with antiviral agents that are active against influenza A and/or B viruses has not been evaluated.
Sočasne uporabe cepiva FLUENZ s protivirusnimi zdravili, ki delujejo proti virusom gripe A in/ali B niso ocenili.
In an active-controlled clinical study (MI-CP111), an increased rate of hospitalisations (for any cause) through 180 days after final vaccination dose was observed in infants and toddlers 6-11 months of age (6.1% FLUENZ versus 2.6% injectable influenza vaccine).
V aktivni kontrolirani klinični študiji (MI-CP111) so opazili povečano stopnjo hospitalizacij (zaradi vseh razlogov) v obdobju 180 dni po končnem odmerku vakcinacije pri dojenčkih in malčkih starih od 6-11 mesecev (6,1% cepivo FLUENZ v primerjavi z 2,6% cepivo proti gripi, ki se injicira).
The adverse reactions reported were similar to those seen with the recommended single dose of FLUENZ.
Neželeni učinki, o katerih so poročali, so bili podobni tistim pri priporočenem enkratnem odmerku cepiva FLUENZ.
Fertility No data exist regarding the possible effects of FLUENZ on male and female fertility.
Plodnost Podatkov o morebitnem vplivu cepiva FLUENZ na plodnost pri moških in ženskah ni.
It is not known whether FLUENZ is excreted in human milk.
Ni znano, ali se cepivo FLUENZ izloča v materino mleko.
5 single-use nasal applicators (0.2 ml each) Store in a refrigerator.
5 nosnikov za enkratno uporabo (vsak po 0,2 ml) Shranjujte v hladilniku.
D153-P514 Europe 6 to 71 M 2,085 2002-2003
D153-P514 Evropa 6 do 71 m 2.085 2002-2003
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 (e.g. gelatin), or to gentamicin (a possible trace residue), eggs or egg proteins (e.g. ovalbumin).
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (npr. želatino) ali gentamicin (možen ostanek v sledeh), jajca ali jajčne beljakovine (npr. ovalbumin).
Fluenz is a vaccine to prevent influenza (flu).
Cepivo Fluenz je cepivo za preprečevanje gripe.
NAME OF THE MARKETING AUTHORISATION HOLDER MedImmune, LLC
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM MedImmune, LLC
Several studies against placebo have shown that FLUENZ may have some efficacy in adults.
Več študij, kjer so cepivo primerjali s placebom, je pokazalo, da cepivo FLUENZ morda nekoliko učinkuje pri odraslih.
If influenza antiviral agents and FLUENZ are administered concomitantly, revaccination should be considered when appropriate.
Pri sočasni uporabi protivirusnih zdravil in cepiva FLUENZ je treba razmisliti o revakcinaciji, če je ustrezno.
D153-P515 Europe fewer cases than injectable fewer cases than injectable a
D153-P515 Evropa 6 do 17 let manj primerov kot pri cepivu, ki se injicira manj primerov kot pri cepivu, ki se injicira a m = meseci.
Fluenz will be administered under the supervision of a doctor, nurse or pharmacist.
Cepivo Fluenz boste prejeli pod nadzorom zdravnika, medicinske sestre ali farmacevta.
Children and adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids.
Otroci in mladostniki s klinično imunodeficienco zaradi bolezni ali imunosupresivnega zdravljenja kot: akutne in kronične oblike levkemije; limfom; simptomatska okužba z virusom HIV; celična imunodeficienca in uporaba kortikosteroidov v visokih odmerkih.
Pregnancy There are limited data from the use of FLUENZ in pregnant women.
Nosečnost Podatkov o uporabi cepiva FLUENZ pri nosečnicah je malo.
Do not inject.
NE INJICIRAJTE.
Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) have also been observed in the post-marketing setting.
Po začetku trženja so opazili zelo redka poročila o Guillain-Barréjevem sindromu in poslabšanju simptomov Leigh-sindroma (mitohondrijska encefalomiopatija).
fewer cases than injectable c fewer cases than injectable
manj primerov kot pri cepivu, ki se injicira c manj primerov kot pri cepivu, ki se injicira
Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
Otroci in mladostniki stari manj kot 18 let, ki se zdravijo s salicilatom zaradi povezave z Reyevim sindromom pri uporabi salicilatov in okužbo z gripo virusa divjega tipa.
You can breathe normally while you are given Fluenz.
Med prejemanjem cepiva Fluenz lahko normalno dihate.
Table 1 FLUENZ Efficacy in Placebo Controlled Paediatric Studies
Preglednica 1 Učinkovitost cepiva FLUENZ v pediatričnih študijah, kontroliranih s placebom
Other possible side effects of Fluenz
Drugi možni neželeni učinki cepiva Fluenz
• Children who have not previously had an influenza vaccine will receive a second, follow-up dose after an interval of at least 4 weeks.
• Otroci, ki se še nikoli niso cepili proti gripi, bodo najmanj po 4 tednih prejeli še drugi, vzdrževalni odmerek.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS (2 X 5 NASAL APPLICATORS)
PODATKI NA ZUNANJI OVOJNINI VELIKOST PAKIRANJA 10 NOSNIKOV ZA ENKRATNO UPORABO (2 X 5 NOSNIKOV)
• FLUENZ is administered as a divided dose in both nostrils.
• Cepivo FLUENZ se aplicira kot razdeljen odmerek v obe nosnici.
10 single-use nasal applicators (0.2 ml each)
10 nosnikov za enkratno uporabo (vsak po 0,2 ml)
In the same study, an increased rate of wheezing through 42 days was observed in infants and toddlers 6-23 months of age (5.9% FLUENZ versus 3.8% injectable influenza vaccine).
V isti študiji so opazili povišano stopnjo sopenja v obdobju 42 dni pri dojenčkih in malčkih starih od 6-23 mesecev (5,9% cepivo FLUENZ v primerjavi s 3,8% cepivo proti gripi, ki se injicira).
What Fluenz looks like and contents of the pack
Izgled cepiva Fluenz in vsebina pakiranja
D153-P501 Asia/Oceania 12 to 35 M 2,764
D153-P501 Azija/ Oceanija 12 do 35 m 2.764
FLUENZ demonstrated 64.4% (1.4, 88.8) fewer cases than injectable influenza vaccine in 476 infants and toddlers 6-23 months of age and 48.2% (12.7, 70.0) fewer cases in 1,579 children 24-71 months of age.
Z cepivom FLUENZ je bilo 64,4% (1,4; 88,8) manj primerov kot pri cepivu proti gripi, ki se injicira, pri 476 dojenčkih in malčkih starih od 6-23 mesecev in 48,2% (12,7; 70,0) manj primerov pri 1.579 otrok starih od 24-71 mesecev.
How to store Fluenz
Kako uporabljati cepivo Fluenz
Peak incidence of vaccine virus recovery occurred 2-3 days post-vaccination in clinical studies.
V kliničnih študijah je bila največja incidenca rekuperacije virusa iz cepiva 2-3 dni po cepljenju.
The suspension is colourless to pale yellow, clear to opalescent.
Suspenzija je brezbarvna do bledorumena, bistra do opalescentna.
This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 10.
Cepivo je v obliki pršila za nos, suspenzije, ki se nahaja v nosniku za enkratno uporabo (0,2 ml) v velikosti pakiranja 10.
FLUENZ is supplied as a 0.2 ml suspension in a single-use nasal applicator (Type 1 glass), with nozzle (polypropylene with polyethylene transfer valve), nozzle tip-protector cap (synthetic rubber), plunger rod, plunger-stopper (butyl rubber), and a dose-divider clip.
Cepivo FLUENZ je na voljo kot 0,2 ml suspenzija v nosniku za enkratno uporabo (steklo tipa 1), s šobo (polipropilen s polietilenskim ventilom za prenos), zaporko za zaščito konice šobe (sintetična guma), batom, batnim zamaškom (butil guma) in sponko za razdelitev odmerka.
It is not recommended to administer FLUENZ to infants and toddlers 12-23 months of age.
Uporaba cepiva FLUENZ pri dojenčkih in malčkih starih od 12-23 mesecev se ne priporoča.
Improved Efficacy (95% CI)
Izboljšana učinkovitost (95-% IZ)