natgillin/translations-raw huggingface dataset:
In a clinical trial, the immunogenicity 21 days after each injection of HUMENZA given 21 days apart has been assessed in 99 adults.
V kliničnem preskušanju so ocenili imunogenost cepiva 21 dni po vsakem injiciranju cepiva HUMENZA cepiva pri 99 odraslih.
Instructions for the administration of the vaccine:
Navodila za dajanje cepiva:
• Post-marketing surveillance
• Opazovano obdobje po začetku trženja
1st dose
1. odmerek
Read all of this leaflet carefully before you receive this vaccine.
Preden prejmete to cepivo, natančno preberite navodilo.
21 days after 2nd dose
21 dni po 2. odmerku
Regarding unsolicited reactions after any vaccination, injection site warmth (4%) was reported in children from 3 to 8 years of age and oropharyngeal pain (6.1%) was reported in adolescents from 9 to 17 years of age.
Glede na spontane reakcije po vsakem cepljenju so poročali o vročem občutku na mestu injiciranja (4 %) pri otrocih starih od 3 do 8 let in orofaringealni bolečini (6,1 %) pri mladostnikih, starih od 9 do 17 let.
One dose of 0.5 ml of the vaccine will be given.
Dobili boste en 0,5-ml odmerek cepiva.
Children and adolescents (from 3 to 17 years of age):
Otroci in mladostniki (od 3 do 17 let starosti):
One pack contains: - One pack containing 10 vials of 1.5 ml of suspension (antigen).
Eno pakiranje vsebuje: - Eno pakiranje vsebuje 10 vial z 1,5 ml suspenzije (antigen).
- One pack containing 10 vials of 4.5 ml of emulsion (adjuvant).
- Eno pakiranje vsebuje 10 vial s 4,5 ml emulzije (adjuvans).
Children below 6 months of age: HUMENZA is not recommended in children below 6 months of age.
Otroci, mlajši od 6 mesecev: Uporaba cepiva HUMENZA pri otrocih v starosti pod 6 meseci ni priporočljiva.
Regarding unsolicited reactions after any vaccination, diarrhoea (4.3 %) was reported in children from 6 to 11 months of age and cough (4.2 %) was reported in children from 12 to 35 months of age.
Glede na spontane reakcije po vsakem cepljenju so poročali o driski (4,3 %) pri otrocih, starih od 6 do 11 mesecev, in kašlju (4,2 %) pri otrocih, starih od 12 do 35 mesecev.
Rabbits dams dosed with vaccine pre-mating and during gestation did not show any effects on embryofetal development.
Injiciranje cepiva kunčjim samicam pred parjenjem in med brejostjo ni pokazala nobenih učinkov na razvoj embria-zarodka.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Tako kot pri vseh cepivih, ki jih injiciramo, morate imeti na voljo ustrezno obliko zdravljenja in zdravniškega nadzora za primer anafilaktične reakcije, ki lahko sledi cepljenju.
AF03 adjuvant composed of squalene, sorbitan oleate, polyoxyethylene cetostearyl ether and mannitol
AF03 adjuvans, sestavljen iz skvalena, sorbitan oleata, makrogol cetil stearileter in manitola
For the dose to be administered, see recommended posology in section
Za odmerek, ki ga je treba aplicirati, glejte priporočila o odmerjanju v
Children from 12 to 23 months old:
Otroci od 12 do 23 meseca starosti:
The severity of these reactions was from grade 1 (mild) to grade 2 (moderate).
Reakcije so bile po intenzivnosti od 1. stopnje (blage) do 2. stopnje (zmerne).
Adolescents 9 to 17 years of age
Mladostniki, stari od 9 do 17 let
Intramuscular use Read the package leaflet before use
intramuskularna uporaba Pred uporabo preberite priloženo navodilo.
After the vaccine is mixed:
Po premešanju cepiva:
Very common: appetite lost, irritability, drowsiness, fever, abnormal crying.
Zelo pogosti: izguba apetita, razdražljivost, zaspanost, zvišana telesna temperatura, neobičajno jokanje.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) (http://www.ema.europa.eu).
Children (N=48) 12 to 35 months
Otroci (N=48) od 6 do 11 mesecev Otroci (N=48) od 12 do 35 mesecev
STATEMENT OF ACTIVE SUBSTANCE(S)
ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK(I)
Children from 24 to 35 months old:
Otroci od 24 do 35 meseca starosti:
NAME OF THE MEDICINAL PRODUCT Adjuvant for HUMENZA emulsion for injection
IME ZDRAVILA Adjuvans za emulzijo za injiciranje za cepivo HUMENZA
One pack containing: - One pack of 10 vials (type I glass) of 1.5 ml suspension (antigen) with stopper (chlorobutyl).
Eno pakiranje vsebuje: - Eno pakiranje z 10 vialami (steklo tipa I) z 1,5 ml suspenzije (antigen) z zamaškom (klorobutil).
The other ingredients are: thiomersal (11.3 micrograms per 0.5 ml dose), sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Pomožne snovi so: tiomersal (11,3 mikrograma na 0,5 ml odmerek), natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogenfosfat in voda za injekcije.
After mixing the content of antigen vial into the adjuvant vial, HUMENZA is an emulsion for injection in a multidose vial containing 10 doses of 0.5 ml.
Po vmešanju vsebine viale z antigenom v vialo z adjuvansom je cepivo HUMENZA emulzija za injiciranje v večodmerni viali, ki vsebuje 10 odmerkov po 0,5 ml. Emulzija je bela in motna.
MIX WITH THE ANTIGEN BEFORE USE
PRED UPORABO PREMEŠAJTE Z ANTIGENOM
Children from 6 to 11 months old:
Otroci od 6 do 11 meseca starosti:
Number of doses after mixing the content of antigen vial into the adjuvant vial: 10 doses of 0.5 ml.
Število odmerkov po vmešanju vsebine viale z antigenom v vialo z adjuvansom: 10 odmerkov po 0,5 ml.
Overall, a higher frequency of injection site reactions and fever was reported in this age group compared to the adolescents.
V splošnem so v tej starostni skupini v primerjavi z mladostniki poročali o večji pogostnosti reakcij na mestu injiciranja in zvišani telesni temperaturi.
Children (from 6 to 35 months of age):
Otroci (v starosti od 6 do 35 mesecev):
Very common: irritability, crying abnormal, appetite lost, drowsiness, fever, vomiting.
Zelo pogosti: razdražljivost, neobičajno jokanje, izguba apetita, zaspanost, zvišana telesna temperatura, bruhanje.
Adolescent from 9 to 17 years old:
Mladostniki od 9 do 17 leta starosti:
Total enrolled subjects N= 18
Skupno vključeni preiskovan ci N = 18
Sanofi Pasteur SA 2, avenue Pont Pasteur F-69007 Lyon France
Sanofi Pasteur SA 2, avenue Pont Pasteur F-69007 Lyon Francija
In a clinical trial, the immunogenicity 21 days after each injection of HUMENZA given 21 days apart has been assessed in 50 children from 3 to 8 years of age and 49 adolescents from 9 to 17 years of age.
V kliničnem preskušanju so imunogenost 21 dni po vsakem injiciranju cepiva HUMENZA ocenili pri 50 otrocih, starih od 3 do 8 let in 49 mladostnikih, starih od 9 do 17 let.
21 days after 2nd dose Seroprotection rate* % [95% CI]
21. dan po 2. odmerku Delež serozaščite* % [95 % IZ]
There are no data on co-administration of HUMENZA with other vaccines.
Podatkov o sočasni uporabi zdravila HUMENZA z drugimi cepivi ni.
NAME OF THE MEDICINAL PRODUCT Antigen for HUMENZA suspension for injection Pandemic influenza vaccine (H1N1)
Antigen za suspenzijo za injiciranje za cepivo HUMENZA cepivo proti pandemski gripi (H1N1)
The rate of grade 3 (severe) reactions was overall low (≤ 2%).
Pojav reakcij 3. stopnje (hude) reakcije je bil v splošnem majhen
In an open-label clinical trial, two doses (0.5 ml) of HUMENZA have been administered at a 3-week interval in 50 children from 3 to 8 years of age and 49 adolescents from 9 to 17 years of age.
V odprtem kliničnem preskušanju so injicirali dva odmerka (0,5 ml) cepiva HUMENZA v 3tedenskem intervalu 50 otrokom, starim od 3 do 8 let, in 49 mladostnikom, starim od 9 do 17 let.
Total enrolled subjects N= 29
Skupno vključeni preiskovan ci N = 29
A minor infection such as a cold should not be problem, but your doctor should advise whether you could still be vaccinated with HUMENZA, - if you are having a blood test to look for evidence of infection with certain viruses.
Blažja okužba, npr. prehlad, ne predstavlja težave, vendar se pred cepljenjem s cepivom HUMENZA o tem vseeno posvetujte s svojim zdravnikom.
Sanofi Pasteur SA - 2, avenue Pont Pasteur - F-69007 Lyon - France
Sanofi Pasteur SA - 2, avenue Pont Pasteur - F-69007 Lyon - Francija
The adjuvant is a white opaque emulsion.
Adjuvans je bela motna emulzija.
- One pack of 10 vials (type I glass) of 4.5 ml emulsion (adjuvant) with stopper (chlorobutyl).
- Eno pakiranje z 10 vialami (steklo tipa I) s 4,5 ml emulzije (adjuvans) z zamaškom (klorobutil).
A reproductive and developmental toxicity study conducted in rabbits with HUMENZA showed no effects on embryo fetal development.
Študija za ugotavljanje vpliva na sposobnost razmnoževanja in razvoj, opravljena na kuncih s cepivom HUMENZA, ni pokazala vpliva na razvoj embria in zarodka.
Seronegative subjects prior to vaccination N= 55
Preiskovanci, ki so bili pred cepljenjem seronegativni N = 55
The seroprotection rate, the seroconversion rate and the seroconversion factor, using haemagglutination inhibiting (HI) method, were as follows:
Delež serozaščite, delež serokonverzije in faktor serokonverzije po metodi zaviranja hemaglutinacije (haemagglutination inhibition) HI so bili naslednji:
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Če se bolnik zdravi z imunosupresivnimi zdravili, je imunski odziv lahko manjši.
HUMENZA has been given "conditional approval".
Cepivo HUMENZA je pridobilo dovoljenje za promet v "izjemnih okoliščinah".
NAME OF THE MEDICINAL PRODUCT HUMENZA suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
HUMENZA suspenzija in emulzija za emulzijo za injiciranje cepivo proti pandemski gripi (H1N1) (delci viriona, inaktivirani, z adjuvansom)
This may include the provision by the MAH of stickers with invented name and batch number with each pack of the vaccine.
V okviru teh ukrepov lahko imetnik dovoljenja za promet z zdravilom zagotovi z vsakim pakiranjem cepiva nalepke z imenom cepiva in številko serije.
21 days after 1st dose Seroprotection rate* % [95% CI]
21. dan po 1. odmerku Delež serozaščite* % [95 % IZ]
You should not receive HUMENZA: - if you have previously had a sudden life-threatening allergic reaction to any ingredient of HUMENZA (these are listed at the end of the leaflet) or to any of the substances that may be present in trace amounts as follows: ovalbumin, egg and chicken proteins, neomycin, octoxinol-9, formaldehyde.
Ne uporabite cepiva HUMENZA: - če ste kdaj imeli nenadno, življenje ogrožajočo alergijsko reakcijo na katerokoli sestavino cepiva HUMENZA (sestavine so navedene na koncu tega navodila) ali katerokoli snov, ki je lahko prisotna v sledovih, in sicer: ovalbumin, jajčne in piščančje beljakovine, neomicin, oktoksinol-9, formaldehid.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant for HUMENZA emulsion for injection IM
IME ZDRAVILA IN POT(I) UPORABE Adjuvans za emulzijo za injiciranje za cepivo HUMENZA i.m.
The vaccine is of a white opaque emulsion appearance.
Cepivo je bela motna emulzija.
Very common: headache, muscular pain, injection site pain.
Zelo pogosti: glavobol, bolečina mišic, bolečina na mestu injiciranja.
This medicinal product has been authorised under a so-called "conditional approval" scheme.
Zdravilo je pridobilo dovoljenje za promet v "izjemnih okoliščinah".
After mixing, the vaccine is a white opaque emulsion.
Zmešano cepivo je belkasta emulzija.
Children from 6 months of age to less than 3 years of age:
Otroci, starejši od 6 mesecev in mlajši od 3 let:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK CONTAINING 1 PACK OF 10 VIALS OF SUSPENSION (ANTIGEN) AND 1 PACK OF 10 VIALS OF EMULSION (ADJUVANT)
PAKIRANJE Z 1 PAKIRANJEM Z 10 VIALAMI SUSPENZIJE (ANTIGEN) IN 1 PAKIRANJEM Z 10 VIALAMI EMULZIJE (ADJUVANS)
If a second dose is administered there should be an interval of at least three weeks between the first and the second dose.
Če se da še drugi odmerek, morajo med prvim in drugim odmerkom preteči vsaj trije tedni.
The seroconversion rate corresponds to the proportion of subjects with a pre-vaccination titer <1:10 achieving a post-vaccination titer ≥1:40, or the proportion of subjects with a ≥four-fold increase from pre- to post-vaccination titer.
Delež serokonverzije odgovarja razmerju, ko so cepljene osebe dosegle od titra pred cepljenjem < 1: 10 titer po cepljenju ≥ 1 : 40 ali je je razmerje pri osebi naraslo ≥ 4 krat glede na titer pred cepljenjem in titer po cepljenju.
Results to be provided in the simplified PSUR.
Rezultati, ki jih je treba posredovati v poenostavljenem periodično posodobljenem varnostnem poročilu.
Seronegative subjects prior to vaccination N= 1
Preiskovanci, ki so bili pred cepljenjem seronegativni N = 1
Children (N=48) 6 to 11 months
Otroci (stari od 6 do 11 mesecev) N = 48
After mixing, HUMENZA should be stored in a refrigerator (2°C-8°C) and should be used within 24 hours.
6 mesecev Po premešanju morate cepivo HUMENZA hraniti v hladilniku (2 °C-8 °C) in uporabiti v 24 urah.
A second dose of vaccine should be given after an interval of at least three weeks.
Drugi odmerek cepiva se lahko da po poteku vsaj treh tednov.
Seronegative subjects prior to vaccination N= 14
Preiskovanci, ki so bili pred cepljenjem seronegativni N = 14
The seroprotection rate, the seroconversion rate and the seroconversion factor, using HI method, were as follows:
Delež serozaščite, delež serokonverzije in faktor serokonverzije po metodi HI so bili naslednji:
Common: injection site warmth.
Pogosti: vročina na mestu injiciranja.
Total enrolled subjects N= 7
Skupno vključeni preiskovan ci N = 7
If a second dose of 0.25 ml is given, this will be administered at least three weeks after the first dose.
Če se da še drugi polovični 0,25-ml odmerek, morajo med prvim in drugim odmerkom preteči vsaj trije tedni.
PACKAGE LEAFLET: INFORMATION FOR THE USER HUMENZA Suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
NAVODILO ZA UPORABO HUMENZA suspenzija in emulzija za emulzijo za injiciranje cepivo proti pandemski gripi (H1N1) (delci viriona, inaktivirani, z adjuvansom)
EXPIRY DATE EXP MM/YYYY
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: MM/LLLL
Seroconversion factor*** [95% CI]
Faktor serokonverzije*** [95 % IZ]
Take special care with HUMENZA: - if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal, ovalbumin, egg and chicken proteins, neomycin, octoxinol-9, formaldehyde (see section 6.
Bodite posebno pozorni pri uporabi cepiva HUMENZA: - če se je pri vas kdaj pojavila kakršnakoli alergijska reakcija poleg nenadne, življenje ogrožajoče alergijske reakcije na katerokoli sestavino cepiva, na tiomersal, ovalbumin, jajčne in piščančje beljakovine, neomicin, oktoksinol-9, formaldehid (glejte poglavje 6, Dodatne informacije).
Name and address of the manufacturers of the biological active substance sanofi pasteur Parc Industriel d'Incarville 27100 Val-de-Reuil France sanofi pasteur
Sanofi Pasteur Parc Industriel d'Incarville 27100 Val-de-Reuil Francija
The use of HUMENZA may be considered during pregnancy and lactation if this is thought to be necessary, taking into account official recommendations.
Ob oceni, da je to potrebno, in ob upoštevanju uradnih priporočil se lahko cepivo HUMENZA uporabi med nosečnostjo in dojenjem.
AF03 adjuvant composed of squalene (33 mg), sorbitan oleate (4.9 mg), polyoxyethylene cetostearyl ether (6.3 mg), mannitol (6.1 mg) per 1 ml
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Adjuvans (AF03), ki ga sestavljajo skvalen (33 miligramov), sorbitan oleat (4,9 miligramov), makrogol cetil stearileter (6,3 miligramov), manitol (6,1 miligramov) na 1 ml.
Very common: headache, feeling generally unwell, muscular pain, shivering.
Zelo pogosti: glavobol, splošno slabo počutje, bolečina mišic, tresavica.
After mixing HUMENZA should be stored in a refrigerator (2°C-8°C) (never place in the freezer) and should be used within 24 hours.
5 Po mešanju shranjujte cepivo HUMENZA v hladilniku (2 °C-8 °C) (nikoli ne zamrznite) in ga porabite v 24 urah.
Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal, and to residues (ovalbumin, egg and chicken proteins, neomycin, octoxinol-9, formaldehyde).
Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaktične reakcije) na zdravilno učinkovino, na katerekoli pomožne snovi, na tiomersal in druge ostanke v sledeh (ovalbumin, jajčne in piščančje beljakovine, neomicin, oktoksinol-9 in formaldehid).
There is no information on administration of the vaccine HUMENZA with other vaccines.
Podatkov o sočasnem dajanju cepiva HUMENZA z drugimi cepivi ni.
AF03 adjuvant composed of squalene (12.4 milligrams), sorbitan oleate (1.9 milligrams), polyoxyethylene cetostearyl ether (2.4 milligrams) and mannitol (2.3 milligrams)
Adjuvans AF03, ki ga sestavljajo skvalen (12,4 miligramov), sorbitan oleat (1,9 miligramov), makrogol cetil stearileter (2,4 miligramov) in manitol (2,3 miligramov).
Seroprotection rate* % [95% CI]
Delež serozaščite* % [95 % IZ]
In an open-label clinical trial, two doses (0.5 ml) of HUMENZA have been administered at a 3-week interval in 153 subjects (99 adults and 54 elderly).
V odprtem kliničnem preskušanju so 153 osebam (99 odraslim in 54 starejšim bolnikom) injicirali dva odmerka (0,5 ml) cepiva HUMENZA v 3-tedenskem intervalu.
The adjuvant (AF03) is composed of squalene (12.4 milligrams), sorbitan oleate (1.9 milligrams), polyoxyethylene cetostearyl ether (2.4 milligrams) and mannitol (2.3 milligrams), per 0.5 ml dose
- Adjuvans: adjuvans (AF03), ki ga sestavljajo skvalen (12,4 miligramov), sorbitan oleat (1,9 miligramov), makrogol cetil stearileter (2,4 miligramov) in manitol (2,3 miligramov) na 0,5 ml odmerek
HUMENZA consists of 2 separate vials: - One vial containing the antigen (suspension) - One vial containing the adjuvant (emulsion)
Zdravilo HUMENZA je sestavljeno iz dveh ločenih vial: - Ena viala vsebuje antigen (suspenzija) - Ena viala vsebuje adjuvans (emulzija)
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (ovalbumin, egg and chicken proteins, neomycin, octoxinol-9, formaldehyde).
Anafilaktične (tj. življenjsko nevarne) reakcije v anamnezi na katerokoli sestavino cepiva ali na ostanke v sledeh (ovalbumin, jajčne in piščančje beljakovine, neomicin, oktoksinol-9, formaldehid).
Emulsion for injection 10 vials
emulzija za injiciranje
Common: injection site bruising, headache, cough.
Pogosti: modrica na mestu injiciranja, glavobol, kašelj.
METHOD OF ADMINISTRATION Mix into the adjuvant vial before use.
POSTOPEK UPORABE Pred uporabo vmešajte v vialo z adjuvansom.
Adverse reactions reported following any vaccination are listed below according to the following frequency:
Opisani neželeni učinki so navedeni po naslednjih skupinah pogostnosti:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 10 VIALS OF SUSPENSION (ANTIGEN)
PODATKI NA ZUNANJI OVOJNINI PAKIRANJE Z 10 VIALAMI SUSPENZIJE ZA INJICIRANJE (ANTIGEN)
Before extemporaneous mix, the two vials (antigen and adjuvant) should be allowed to reach room temperature and must be gently swirled between hands and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Viali nežno obračajte med rokama in ju vizualno preglejte, ali vsebujeta tujke in/ali sta neobičajnega videza.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 10 VIALS OF EMULSION (ADJUVANT)
PODATKI NA ZUNANJI OVOJNINI PAKIRANJE Z 10 VIALAMI EMULZIJE ZA INJICIRANJE (ADJUVANS)
A higher frequency of headache was reported in this age group compared to the children, adults and elderly.
V primerjavi z otroci, odraslimi in starostniki so v tej starostni skupini poročali o večji pogostnosti glavobola.
Malaise
Odmerjanje
Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Viala z antigenom: tiomersal natrijev klorid kalijev klorid natrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
Pharmacovigilance The MAH commits to submit the data from pregnancy
Farmakovigilanca Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo posredoval podatke iz svojega internega registra nosečnosti kot je zabeleženo v Načrtu za obvladovanje
Split influenza virus*, inactivated containing antigen equivalent to: A/California/7/2009 (H1N1)-like strain (NYMC X-179A).......................................3.8 micrograms**
Po premešanju 1 odmerek (0,5 ml) vsebuje: inaktivirane delce virusa gripe, ki vsebujejo antigene*, ki ustrezajo: sevu A/California/7/2009 (X-179A) podobnemu sevu A/California/7/2009 (H1N1).........3,8 mikrogramov** * namnožen v jajcih ** izražen v mikrogramih hemaglutinina
Excipients: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Pomožne snovi: natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogen fosfat in voda za injekcije.
Excipients: thiomersal, sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Pomožne snovi: tiomersal, natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogenfosfat in voda za injekcije.
Seroconversion rate** % [95% CI]
Delež serokonverzije** % [95 % IZ]
Children from 6 months to less than 3 years of age:
Otroci od 6 mesecev do 3 let starosti:
Suspension and emulsion for emulsion for injection.
suspenzija in emulzija za emulzijo za injiciranje Antigen je brezbarvna, bistra do opalescentna suspenzija.
Children from 6 to 35 months of age:
Otroci, stari od 6 do 35 mesecev:
Very common: feeling generally unwell, muscular pain, headache, shivering, fever.
Zelo pogosti: splošno slabo počutje, bolečina mišic, glavobol, tresavica, zvišana telesna temperatura.
* Proportion of subjects achieving a post-vaccination titer ≥1:40 ** For subjects with a pre-vaccination titer <1:10, proportion of subjects with a post-vaccination titer ≥1:40 and for subjects with a pre-vaccination titer ≥1:10, proportion of subjects with a ≥four-fold increase from pre- to post-vaccination titer *** Geometric mean of individual ratios (post-/pre-vaccination titers)
* Razmerje oseb, ki imajo po cepljenju titer ≥ 1 : 40 ** Za osebe, ki imajo pred cepljenjem titer < 1 : 10 ., razmerje oseb, ki imajo po cepljenju titer ≥ 1 : 40, in za osebe, ki imajo pred cepljenjem titer ≥ 1 : 10 , razmerje oseb z ≥ štirikratnim porastom titra po cepljenju glede na titer pred cepljenjem *** Geometrično povprečje posameznih razmerij (titri pred cepljenjem in po njem)
In an open-label clinical trial, two half-doses (0.25 ml) of HUMENZA have been administered at a 3week interval in 48 children from 6 to 11 months of age and in 48 children from 12 to 35 months of age.
V odprtem kliničnem preskušanju so 48 otrokom, starim od 6 do 11 mesecev in 48 otrokom, starim od 12 do 35 mesecev, aplicirali dva polovična odmerka (0,25 ml) cepiva HUMENZA v 3-tedenskem intervalu.
Total enrolled subjects N= 49
Skupno vključeni preiskovanci N = 99
STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus*, inactivated, containing antigen equivalent to: A/California/7/2009 (H1N1)-like strain (NYMC X-179A)..............................................................30 µg** For 1 ml
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Po premešanju 1 odmerek (0,5 ml) vsebuje: inaktivirane delce virusa gripe, ki vsebujejo antigene*, ki ustrezajo: sevu A/California/7/2009 (X-179A) podobnemu sevu A/California/7/2009 (H1N1)....................................................................................................................3,8 mikrogramov** * namnožen v jajcih ** hemaglutinin
The seroprotection rate corresponds to the proportion of subjects achieving a post-vaccination titer
Delež serozaščite odgovarja razmerju, ko so cepljene osebe dosegle titer po cepljenju ≥ 1 : 40.