natgillin/translations-raw huggingface dataset:
Generalised skin reactions including itching, bumps on the skin or a non-specific rash.
Splošne kožne reakcije, kot so srbenje, bule na koži ali neznačilni izpuščaj.
Serologic responses obtained with the HI assay showed that 92% of subjects achieved seroprotection and 75% seroconverted after two 7.5 µg injections.
pridobljen z metodo HI, je pokazal, da je do serološke zaščite prišlo pri 92 % oseb in da se je po dveh 7,5-mikrogramskih injekcijah pri 75 % pojavila serološka konverzija.
- Guillain-Barré narrow SMQ “Guillain-Barré syndrome”
zoženo SMQ „Vaskulitis“ - Guillain-Barréjev sindrom: zoženo SMQ „Guillain-Barréjev sindrom“ - Demielinacija:
PT “Neuritis”
PI „Nevritis“
Non-clinical data obtained with Foclivia and with seasonal influenza vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of repeated dose toxicity, local tolerance, female fertility, and reproductive and developmental toxicity (through the end of the lactation period).
Neklinični podatki, pridobljeni z zdravilom Foclivia in cepivom proti sezonski gripi, ki je vsebovalo adjuvans MF59C.1, na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih, lokalne tolerance, plodnosti pri ženskah ter vpliva na sposobnost razmnoževanja in razvoja (do konca obdobja dojenja) ne kažejo posebnega tveganja za človeka.
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
MN results against a A/Vietnam/1194/2004 indicate a seroprotection rate of 99% (95%CI: 94-100), a seroconversion rate ranging from 97% (95%CI: 91-99) to 99% (95%CI: 96-100) and a GMR ranging from 29 (95%CI: 25-35) to 50 (95%CI: 44-58).
Rezultati MN za sev A/Vietnam/1194/2004 kažejo na stopnjo serozaščite 99 % (95-odstotni IZ: 94100), stopnjo serokonverzije v razponu od 97 % (95-odstotni IZ: 91-99) do 99 % (95-odstotni IZ: 96100) in GMR v razponu od 29 (95-odstotni IZ: 25-35) do 50 (95-odstotni IZ: 44-58).
Adverse reactions in the week following vaccination with Focetria H1N1v from 77 children 3-8 years old and 80 children and adolescents 9-17 years old receiving the 7.5 µg formulation were reported as follows:
Neželeni učinki v tednu po cepljenju z zdravilom Focetria H1N1 pri 77 otrocih, starih 3-8 let, in 80 otrocih in mladostnikih, starih 9-17 let, ki so prejeli formulacijo 7,5 µg, so bili, kot sledi:
To be administered intramuscularly into the deltoid muscle.
Uporabiti je treba intramuskularno v deltoidno mišico.
However, in a pandemic situation, you may still be given the vaccine.
Vendar boste v pandemični situaciji v primeru, da dobite alergijsko reakcijo, še vedno lahko prejeli cepivo, če bo nemudoma na voljo zdravljenje.
tiredness, headache, sweating, pain in muscles and joints.
tresenje, utrujenost, glavobol, potenje, bolečine v mišicah in sklepih.
Warnings and precautions Talk to your doctor or nurse before having this vaccine:
Opozorila in previdnostni ukrepi Pred cepljenjem se posvetujte z zdravnikom ali medicinsko sestro:
- have experienced serious allergic reaction (i.e. life-threatening) to any of the constituents of Foclivia, - are allergic (hypersensitive) to influenza vaccines or any of the ingredients of Foclivia, - are allergic to eggs, chicken protein, - are allergic to any antibiotic, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80.
- ste alergični na (preobčutljivi za) cepiva proti gripi ali katerokoli sestavino zdravila Foclivia, - ste alergični na jajca, piščančje beljakovine, - ste alergični na katerikoli antibiotik, formaldehid, cetiltrimetilamonijev bromid (CTAB) in polisorbat 80
Some cross-protection was observed against related H5N1 virus variants in clinical trials (see section 5.1).
V kliničnih preskušanjih so opazili določeno stopnjo navzkrižne zaščite proti sorodnim različicam virusa H5N1 (glejte poglavje 5.1).
It is essentially sodium- and potassium-free.
Zdravilo je v bistvu brez natrija in kalija.
To put the safety report into context, a summary of vaccine distribution should be included and should provide details of the number of doses of vaccine distributed in i) EU member states for the reporting period by batch number, ii) EU member states cumulatively and iii) the rest of the world.
i) državah članicah EU, po številki serije za obdobje poročanja, ii) državah članicah EU kumulativno in iii) ostalih državah.
- Except for Table 1, all tables will be based on number of reactions (presented on PT level, sorted by System Organ Class [SOC] and High Level Term [HLT]) and not number of cases.
- Razen za tabelo 1 temeljijo vse tabele na številu učinkov (predstavljenih na ravni PI,
In a phase II clinical trial (Study V87P6) safety of a pandemic preparedness adjuvanted H5N1 vaccine was evaluated in children and adolescent (see section 5.1 for more information).
faze (študija V87P6) so ocenili varnost cepiva proti gripi H5N1 za pripravljenost na pandemijo z dodanim adjuvansom pri otrocih in mladostnikih (za več informacij glejte poglavje 5.1).
Adolescents(9-<18 years)
Mladostniki (9-<18 let)
Skin and subcutaneous tissue disorders Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Bolezni kože in podkožja generalizirane kožne reakcije, vključno s srbenjem, urtikarijo ali nespecifičnim izpuščajem;
Safety data are available, however, in pregnant women exposed to Focetria (an H1N1 pandemic vaccine similar to Foclivia) which contains the same amount of MF59C.1 as Foclivia.
Varnostni podatki pa so na voljo za nosečnice, ki so bile izpostavljene zdravilu Focetria (cepivo proti pandemični gripi H1N1, ki vsebuje adjuvans MF59.1 in je podobno zdravilu Focetria).
- S-PSUR submission to the Rapporteur and CHMP members on Day 45.
- Predložitev S-PSUR poročevalcu in članom Odbora za zdravila za uporabo v humani medicini
Common (>1/100, <1/10): headache
Pogosti (>1/100, <1/10): glavobol
In two dose finding studies 78 adults received an adjuvanted pandemic preparedness vaccine (H5N3 or H9N2).
• Podporne študije pri odraslih in starejši populaciji V dveh študijah za določanje odmerka je 78 odraslih oseb prejelo cepivo za pripravljenost na pandemijo (H5N3 ali H9N2) z dodanim adjuvansom.
An overview for all spontaneous cases per country, stratified according to type of report (medically confirmed or non-medically confirmed) and seriousness, for the period covered by the report and cumulatively.
Pregled za vse spontane primere na državo, stratificirane glede na vrsto poročila (medicinsko potrjena ali nemedicinsko potrjena) in glede na resnost za obdobje, ki ga poročilo pokriva, ter kumulativno.
Seroconversion factor (95%CI)°°
Faktor serokonverzije (95-odstotni IZ)°°
Very rare (may affect up to 1 in 10,000 people).
Zelo redki (se lahko pojavijo pri največ 1 cepljeni osebi od 10.000 cepljenih oseb).
Foclivia 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 Foclivia takes due account of the officially declared pandemic strain.
Zdravilo Foclivia se lahko trži samo, kadar SZO/EU uradno razglasi pandemijo gripe, pod pogojem,
It is provided in a ready-to-use syringe, containing a single dose (0.5 ml) for injection, in box of 1 or 10, with or without needle.
Na voljo je v napolnjenih injekcijskih brizgah z iglo ali brez nje, ki vsebujejo enkratni odmerek (0,5 ml) za injiciranje, v škatli z 1 ali10 injekcijskimi brizgami.
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues of eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB) of this vaccine.
Anafilaktične (tj. smrtno nevarne) reakcije v anamnezi na katero koli sestavino cepiva ali ostanke jajc v sledovih, piščančje beljakovine, kanamicin in neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid (CTAB) v cepivu.
MN results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from of 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69) respectively.
Rezultati MN za A/Vietnam/1194/2004 kažejo na stopnjo serozaščite v razponu od 57 % (50-64) do 79 % (68-87) in stopnjo serokonverzije v razponu od 55 % (48-62) do 58 % (47-69).
Injection 3
3. injekcija
narrow SMQ “Convulsions”
zoženo standardizirano povpraševanje po MedDRA (SMQ) „Konvulzije“
Study V87P1 Adults Booster (6 months after 2nd dose
Študija V87P1 starejši obnovitveni odmerek (6 mesecev po 2. odmerku)
MicroNeutralization (MN) results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from 67% (60-74) to 85% (78-90) and 65% (58-72) to 83% (77-89), respectively.
Rezultati mikronevtralizacije (MN) za A/Vietnam/1194/2004 kažejo na stopnjo serozaščite v razponu od 67 % (60-74) do 85 % (78-90) in stopnjo serokonverzije v razponu od 65 % (58-72) do 83 % (7789).
1.175 milligrams
1,175 miligramov sorbitantrioleat
Fever ≥38°C to 38.9°C Fever 39°C to 39.9°C Fever ≥ 40° C Any other AE
Zvišana telesna temperatura ≥ 38 °C do 38,9 °C
0.5 ml in pre-filled syringe (type I glass) with plunger-stopper (bromo-butyl rubber).
0,5 ml v napolnjeni injekcijski brizgi (steklo vrste I) z batnim zamaškom (iz bromobutilne gume).
One dose (0.5 ml) contains: Active Ingredients: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in fertilised hen's eggs from healthy chicken flocks, and adjuvanted with MF59C.1, of strain:
En odmerek (0,5 ml) vsebuje učinkovine: površinski antigeni (hemaglutinin in nevraminidaza), namnoženi v oplojenih kokošjih jajcih iz jat zdravih piščancev, z dodanim adjuvansom MF59C.1, seva virusa influence: A/Vietnam/1194/2004 (H5N1)
MN results in study V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.01 (1.78-2.26).
Rezultati MN v študiji V87P13 so pokazali GMR proti sevu A/turkey/Turkey/05 2,01 (1,78-2,26).
Common (>1/100, <1/10): sweating
Pogosti (>1/100, <1/10): potenje
The adjuvanted vaccine was also found to induce antibodies that cross-protected against the H5N1 strains isolated in 2003 and 2004, which exhibit some antigenic drift compared to the original strains.
izoliranim v letih 2003 in 2004, ki so kazala določen antigenski odmik v primerjavi z izvirnimi sevi.
Suspension for injection in pre-filled syringe.
suspenzija za injiciranje v napolnjeni injekcijski brizgi mlečno bela tekočina
Two doses of vaccine with H5N3 (A/Duck/Singapore/97) strain at 3 different dosages (7.5, 15 and 30 µg HA/dose) were administered three weeks apart.
H5N3 (A/Duck/Singapore/97) so uporabili v presledku treh tednov pri treh različnih odmerkih
The seroprotection rate and seroconversion rate measured by HI assay and the seroconversion factor expressed as geometric mean ratio of HI for anti-HA antibody to H1N1 after administration of one and two 7.5 µg doses of Focetria was evaluated in 70 children and adolescents (9-17 years), 60 children (3-8 years), 58 children (12-35 months) and 49 infants (6-11 months).
Stopnji serozaščite in serokonverzije, izmerjeni z metodo HI, in faktor serokonverzije, izražen kot geometrijska srednja vrednost razmerja HI za protitelo proti HA in H1N1, so po dajanju enega in dveh 7,5 µg odmerkov zdravila Focetria ocenili pri 70 otrocih in mladostnikih (9-17 let), 60 otrocih (3-8 let), 58 otrocih (12-35 mesecev) in 49 dojenčkih (6-11 mesecev).
Seroconversion factor(95%CI)**
Faktor serokonverzije (95-odstotni IZ)**
Warnings and precautions Talk to your doctor or nurse before having this vaccine.
Opozorila in previdnostni ukrepi Pred cepljenjem se posvetujte z zdravnikom ali medicinsko sestro.
Respiratory, thoracic and mediastinal disorders Cough.
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj
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 (iz halobutilne gume).
Contents of the pack and other information
Shranjevanje zdravila Foclivia Vsebina pakiranja in dodatne informacije
MN results in V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.77 (2.4-3.2).
Rezultati MN v V87P13 so pokazali GMR proti sevu A/turkey/Turkey/05 2,77 (2,4-3,2).
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1, to thiomersal and to eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB).
Pri uporabi tega cepiva pri osebah z znano preobčutljivostjo (razen anafilaktičnih reakcij) na učinkovino, katero koli pomožno snov, navedeno v poglavju 6.1, na tiomersal in na jajca, piščančje beljakovine, kanamicin in neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid (CTAB) je treba biti previden.
Prior to administration, the withdrawn vaccine should be allowed to reach room temperature.
S cepivom napolnjeno brizgo pred dajanjem pustite, da se ogreje na sobno temperaturo.
From Post-marketing surveillance with adjuvanted interpandemic trivalent vaccines with composition similar to that of Foclivia (an MF59C.1 adjuvanted H1N1 pandemic vaccines), the following additional adverse reactions have been reported:
V nadzoru v obdobju trženja interpandemičnih trivalentnih cepiv z adjuvansom, katerih sestava je bila podobna zdravilu Foclivia (cepivu proti pandemski gripi H1N1 z adjuvansom MF59C.1), so poročali o naslednjih dodatnih neželenih učinkih:
Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2nd dose in adults 18-60 years of age, measured by SRH and HI assays were as follows:
Stopnja serozaščite*, delež serokonverzije* in faktor serokonverzije** za protitelesa proti HA na H5N1 A/turkey/Turkey/05 po 2. odmerku pri odraslih, starih 18-60 let, izmerjeni s testi SRH in HI, so bili, kot sledi:
9.75 milligrams
9,75 miligramov polisorbat 80
MN results in study V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.77 (2.4-3.2).
Rezultati MN v študiji V87P13 so pokazali GMR proti sevu A/turkey/Turkey/05 2,77 (2,4-3,2).
0.5 ml in single-dose vial (type I glass) with stopper (halo-butyl rubber).
0,5 ml v viali z enkratnim odmerkom (steklo vrste I) z zamaškom (iz halobutilne gume).
Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2nd dose in elderly >60 years of age, measured by SRH and HI assays were as follows:
Stopnja serozaščite*, delež serokonverzije* in faktor serokonverzije** za protitelesa proti HA na H5N1 A/turkey/Turkey/05 po 2. odmerku pri starejših, starih > 60 let, izmerjeni s testi SRH in HI, so bili, kot sledi:
Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event
Zvišana telesna temperatura ≥ 40 °C Vsi drugi neželeni učinki
- Active substance:
- Pomožne snovi:
Rare (may affect up to 1 in 1,000 people).
Redki (se lahko pojavijo pri največ 1 cepljeni osebi od 1.000 cepljenih oseb).
What is n this leaflet:
Kaj vsebuje navodilo
While no data is available from the use of Foclivia, cases of convulsion with and without fever have been reported in subjects vaccinated with Focetria an MF59.1 adjuvanted H1N1 pandemic vaccine similar to Foclivia.
Čeprav podatkov o uporabi zdravila Foclivia ni, so pri osebah, ki so prejele zdravilo Focetria (cepivo proti pandemični gripi H1N1, ki vsebuje adjuvans MF59.1 in je podobno zdravilu Focetria), ugotovili primere konvulzij z zvišano telesno temperaturo in brez nje.
Ready-to-use syringe, containing a single dose of 0.5 ml for injection.
Napolnjena injekcijska brizga, ki vsebuje enkratni odmerek (0,5 ml) za injiciranje.
An overview for all spontaneous adverse reactions by SOC, High Level Term (HLT) and Preferred Term (PT), stratified according to type of report (medically confirmed or non-medically confirmed) and including the number of fatal reports, for the period covered by the report and cumulatively.
Pregled vseh spontanih neželenih učinkov po organskih sistemih (OS), izrazih na visoki ravni (High Level Term - HLT) in prednostnih izrazih (PI), stratificirani glede na vrsto poročila (medicinsko potrjeno ali nemedicinsko potrjeno) z vključitvijo števila fatalnih poročil za obdobje, ki ga krije poročilo, in kumulativno.
Two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HemoAgglutinin (HA)/dose adjuvanted) were administered three weeks apart to 156 subjects.
V 3-tedenskem presledku so 156 preiskovancev cepili s cepivom, ki je vsebovalo H5N1 (A/Vietnam/1194/2004; 7,5 µg hemaglutinina (HA)/odmerek z adjuvansom).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 1-DOSE VIAL
PODATKI NA ZUNANJI OVOJNINI KARTONASTA ŠKATLA ZA VIALO Z ENIM ODMERKOM
Gently shake the multidose vial each time before withdrawing a dose (0.5 ml) of the vaccine into a syringe.
Pred vsakim odvzemom odmerka (0,5 ml) cepiva v brizgo previdno pretresite večodmerno vialo.
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.
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).
0.66 milligrams
0,66 miligramov citronska kislina
MN results for the clinical studies in the Table above revealed a seroprotection rate against A/turkey/Turkey/05 ranging from 27% (17-39) (V87P1) to 39% (32-46) (V87P13) and seroconversion rate of 36% (29-43) for study V87P13.
A/turkey/Turkey/05 v razponu od 27 % (17-39) (V87P1) do 39 % (32-46) (V87P13) in stopnjo serokonverzije 36 % (29-43) za študijo V87P13.
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in subjects aged over 60 (limited number of subjects were above 70 years of age) measured by SRH assay assessed in two clinical studies were as follows:
H5N1 A/Vietnam/1194/2004 pri preiskovancih, starejših od 60 let (omejeno število preiskovancev je bilo starejših od 70 let), izmerjeni s testom SRH in ocenjeni v dveh kliničnih študijah, so bili, kot sledi:
A clinical trial (Study V87P6) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant (n=334) vs seasonal influenza vaccine (n=137).
MF59C.1 (n = 334), s sezonskim cepivom proti gripi (n = 137).
7.5 micrograms haemagglutinin
7,5 mikrogramov hemaglutinina
Seroprotection rate (95%CI)° Seroconversion rate (95%CI)°
Stopnja serozaščite (95-odstotni IZ)° Delež serokonverzije (95-odstotni IZ)°
A Phase II clinical trial (Study V87P1) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 312 healthy adults.
Pri 312 zdravih odraslih prostovoljcih so izvedli klinično preskušanje 2. faze (študija V87P1) s kombinacijo cepiva H5N1 in adjuvansa MF59C.1.
CHMP immunogenicity criteria set for adults (18-60 years) were met both after the 1st and the 2nd dose in all the above age strata (both in the overall population and in the subset seronegative at baseline).
V vseh navedenih starostnih skupinah (v celotni populaciji in v podskupini v izhodišču seronegativnih oseb) so bili po prvem in drugem odmerku doseženi kriteriji CHMP za imunogenost za odrasle (18-60 let).
MN results for the clinical studies in the Table above revealed a seroprotection rate against A/turkey/Turkey/05 ranging from 11% (3-25) (study V87P1) to 30% (24-37) (study V87P13) and seroconversion rate of 25% (19-31) for study V87P13.
A/turkey/Turkey/05 v razponu od 11 % (3-25) (študija V87P1) do 30 % (24-37) (študija V87P13) in stopnjo serokonverzije 25 % (19-31) za študijo V87P13.
Package leaflet: Information for the user Foclivia suspension for injection in multidose container
Foclivia suspenzija za injiciranje v vsebniku z več odmerki.
ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT E. SPECIFIC OBLIGATIONS TO COMPLETE POST AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
It is provided in a vial containing a single dose (0.5 ml) for injection.
Na voljo je v vialah, ki vsebujejo enkratni odmerek (0,5 ml) za injiciranje.
Adverse reactions in the week following vaccination with Focetria H1N1v from 73 infants 6-11 months old and 73 toddlers 12-35 months old, receiving the 7.5 µg formulation were reported as follows:
11 mesecev, in 73 malčkih, starih 12-35 mesecev, ki so prejeli formulacijo 7,5 µg, so bili, kot sledi:
Persistence of antibodies after primary vaccination in this population as assessed by HI, SRH, and MN tests reduced from 1/2 to 1/5th of their post-vaccination level at day 202 as compared to day 43 after completion of primary schedules as assessed by HI, SRH, and MN tests.
V primerjavi z ravnmi protiteles, pridobljenimi 43. dan po zaključku primarnega režima cepljenja, so bile ravni protiteles 202. dan zmanjšane od 1/5 do 1/2 glede na predhodne ravni, izmerjene s testi HI, SRH in MN. Do 50 % starejših oseb, imuniziranih s cepivom proti H5N1 z dodanim MF59C, je bilo v šestem mesecu serozaščitenih.
Serious unlisted adverse reactions (SOC, HLT, PTs) stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Hudi nenavedeni neželeni učinki (OS, HLT, PI), stratificirani glede na vrsto poročila (medicinsko potrjena ali nemedicinsko potrjena) in glede na obdobje, ki ga poročilo pokriva, ter kumulativno.
Common (may affect up to 1 in 10 people).
Pogosti (se lahko pojavijo pri največ 1 cepljeni osebi od 10 cepljenih oseb).
All spontaneous adverse reactions (SOC, HLT, PT) occurring in pregnant women, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Vsi spontani neželeni učinki (OS, HLT, PI) pri nosečnicah, stratificirani glede na vrsto poročila (medicinsko potrjena ali nemedicinsko potrjena) in glede na obdobje, ki ga poročilo pokriva, ter kumulativno.
All spontaneous adverse reactions by age group, per SOC, HLT and PT, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Vsi spontani neželeni učinki glede na starostno skupino po OS, HLT in PI, stratificirani glede na vrsto poročila (medicinsko potrjena ali nemedicinsko potrjena) in glede na obdobje, ki ga poročilo pokriva, ter kumulativno.
You should discuss with your doctor whether you should receive Foclivia.
O cepljenju z zdravilom FOCLIVIA se posvetujte z zdravnikom.
Uncommon: (may affect up to 1 in 100 people).
Občasni (se lahko pojavijo pri največ 1 cepljeni osebi od 100 cepljenih oseb).
It is provided in a vial containing ten doses (0.5 ml each) for injection.
Viala vsebuje 10 odmerkov (0,5 ml na odmerek) za injiciranje.
Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted) I.M.
cepivo proti pandemični gripi (površinski antigeni, inaktivirani, z adjuvansom)
Baseline Serostatus
Serostatus ob izhodišču
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)**
Delež serokonverzije (95-odstotni IZ)* Faktor serokonverzije (95-odstotni IZ)**
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR 10-DOSE VIAL
OVOJNINAH OZNAKA ZA VIALO Z DESETIMI ODMERKI
Therefore, tell the doctor or nurse if you fainted with a previous injection.
če ste omedleli pri kakšnem prejšnjem injiciranju.
Study V87P1 21 days after 2nd dose N=84
Študija V87P1 21. dan po 2. odmerku n = 84
Study V87P13 21 days after 2nd dose N=66
Študija V87P13 21. dan po 2. odmerku n = 66