natgillin/translations-raw huggingface dataset:
71-80 years 21 days after 1st dose 21 days after 2nd dose 21 days after 1st dose 21 days after 2nd dose
71-80 let 21 dni po 1. odmerku 21 dni po 2. odmerku 21 dni po 1. odmerku 21 dni po 2. odmerku Skupno vključeni preiskovanci n=75 [95% IZ]
Data obtained on the administration of a non-adjuvanted seasonal influenza vaccine (Fluarix, as above) three weeks before a dose of Pandemrix (H1N1)v in healthy adults over 60 years of age, did not suggest any significant interference in the immune response to Pandemrix (H1N1)v. Therefore the data indicate that Pandemrix may be administered three weeks after the administration of non-adjuvanted seasonal influenza vaccines.
Podatki o uporabi cepiva proti sezonski gripi brez adjuvansa (Fluarix, kot je navedeno zgoraj) tri tedne pred odmerkom cepiva Pandemrix (H1N1)v pri zdravih odraslih, starejših od 60 let, ne kažejo pomembnega vpliva na imunski odziv na cepivo Pandemrix (H1N1)v. Podatki torej kažejo, da se cepivo Pandemrix lahko uporabi tri tedne po uporabi cepiva proti sezonski gripi brez adjuvansa.
CI]
IZ]
Pandemrix contains thiomersal
Cepivo Pandemrix vsebuje tiomersal
NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Pandemrix
IME ZDRAVILA Emulzija za emulzijo za injiciranje za cepivo Pandemrix
In a clinical study where a non-adjuvanted seasonal influenza vaccine (Fluarix, as above) was administered 3 weeks after the second dose of Pandemrix (two doses were given 21 days apart), a lower immune response to Fluarix was observed as compared to subjects who had not previously received Pandemrix.
V klinični študiji, v kateri so tri tedne po drugem odmerku cepiva Pandemrix (dva odmerka sta bila uporabljena 21 dni narazen) uporabili cepivo proti sezonski gripi brez adjuvansa (Fluarix, kot je navedeno zgoraj), so opazili manjši imunski odziv na cepivo Fluarix v primerjavi s preiskovanci, ki predhodno niso prejeli cepiva Pandemrix.
In children aged 6 to 35 months (N=51) who received two doses of 0.25 ml (half of the adult dose) with an interval of 3 weeks between doses there was an increase in the rates of injection site reactions and general symptoms after the second dose (see section 4.8).
Pri otrocih, starih od 6 do 35 mesecev (n = 51), ki so dobili dva odmerka 0,25 ml (polovični odmerek za odrasle) v presledku 3 tednov med odmerkoma, se je po drugem odmerku pojavil večji delež reakcij na mestu injiciranja in splošnih simptomov (glejte poglavje 4.8).
Month N=24
mesec n=24
• Swollen glands in the neck, armpit or groin
• otekle bezgavke na vratu, pod pazduhami ali v dimljah,
2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold increase in titre;
2Delež serokonverzije: delež preiskovancev, ki so bili pred cepljenjem seronegativni in imajo po cepljenju zaščitni titer ≥ 1:40, ali so bili pred cepljenjem seropozitivni in imajo 4-kraten porast titra;
Twelve months after the first dose, the seroprotection rates in the children who had received two half (0.25 ml) doses were 90.2% and 100% in those who had received two full (0.5 ml) adult doses.
Dvanajst mesecev po prvem odmerku je bil delež serološke zaščite 90,2 % pri otrocih, ki so prejeli dva polovična odmerka (0,25 ml), pri tistih, ki so prejeli dva polna odmerka za odrasle (0,5 ml) pa 100 %.
Total enrolled subjects N=120
Skupno vključeni preiskovanci n=120
Post-marketing experience with trivalent seasonal influenza vaccines Blood and lymphatic system disorders
Izkušnje s trivalentnimi sezonskimi cepivi proti gripi med obdobjem trženja
In children 3 to 9 years of age who received two 0.25 ml doses of Pandemrix (H1N1) the side effects reported were similar to those reported in adults, except for redness at the injection site and gastrointestinal symptoms which were very common and shivering and sweating which were common.
Pri otrocih, starih od 3 do 9 let, ki so dobili dva 0,25 ml odmerka cepiva Pandemrix (H1N1), so bili opisani neželeni učinki podobni kot pri odraslih, z izjemo rdečine ne mestu injiciranja in prebavnih simptomov, ki so bili zelo pogosti, ter drgetanja in znojenja, ki sta bila pogosta.
• Tingling or numbness of the hands or feet
• mravljinčenje ali odrevenelost v rokah ali nogah, • nespečnost,
Suspension and emulsion for emulsion for injection
suspenzija in emulzija za emulzijo za injiciranje
Pandemrix contains sodium and potassium
Cepivo Pandemrix vsebuje natrij in kalij
• A long-term condition with excessive daytime sleepiness (narcolepsy), with or without sudden weakness (cataplexy), which may lead to falls without loss of consciousness
• dolgotrajna motnja s čezmerno zaspanostjo čez dan (narkolepsija), z nenadno mišično šibkostjo
• Fits due to fever
• krči zaradi zvišane telesne temperature;
Very rare (<1/10,000)
Zelo pogosti (≥ 1/10)
NA NA NA NA 27.7% 20.6% 35.1% 49.1%
Utrujenost np np np np 27,7 % 20,6 % 35,1 % 49,1 %
See section 5.1 regarding immune responses to one and two doses of Pandemrix (H1N1)v, including antibody levels after 6 and 12 months.
Glede imunskih odzivov na en odmerek in dva odmerka cepiva Pandemrix (H1N1)v, vključno z ravnjo protiteles po 6 in 12 mesecih, glejte poglavje 5.1.
Before the vaccine is mixed:
Pred premešanjem cepiva
Clinical trials Blood and lymphatic system disorders
Klinična preskušanja Bolezni krvi in limfatičnega sistema občasni limfadenopatija
Gastrointestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Bolezni prebavil pogosti gastrointestinalni simptomi (na primer driska, bruhanje, bolečine v trebuhu,
Excessive sleepiness during the day, often at the wrong times (a long-term condition called narcolepsy), has been reported very rarely after vaccination with Pandemrix in several European countries.
V več evropskih državah so po cepljenju s cepivom Pandemrix zelo redko poročali o prekomerni zaspanosti čez dan, pogosto ob nepravem času (kronična motnja, imenovana narkolepsija).
Month N=10
mesec n=10
There are no data on co-administration of Pandemrix with other vaccines.
Podatkov o sočasni uporabi cepiva Pandemrix z drugimi cepivi ni.
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 listed in section 6.1, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaktične reakcije) za zdravilno učinkovino, katerokoli pomožno snov navedeno v poglavju 6.1, tiomersal ali ostanke (jajčne in piščančje beljakovine, ovalbumin, formaldehid, gentamicinijev sulfat ali natrijev deoksiholat).
There is no information on administration of Pandemrix with other vaccines.
O uporabi cepiva Pandemrix z drugimi cepivi ni podatkov.
Please consult the Product Information of Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted).
Glejte informacije o cepivu Cepivo proti pandemski gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom).
Half adult dose
Polovični odmerek za odrasle
N=60 N=56 N=53 N=52 N=65 N=63 N=57 N=57
Po 2. odmerku n=34 n=32 n=30 n=28 n=15 n=15 n=14 n=14
NA NA NA NA 13.8% 7.9% 15.8% 14.0%
Prebavni np np np np 13,8 % 7,9 % 15,8 % 14,0 %
Redness Swelling Fever (>38°C) axillary
Zvišana telesna temperatura (> 38 °C) aksilarno
6-9 years
Od 6 do 9 let
In clinical studies that evaluated reactogenicity in adults aged 18 years and above who received two 0.5 ml doses of Pandemrix (H1N1)v, higher rates of general solicited symptoms (such as fatigue, headache, arthralgia, myalgia, shivering, sweating and fever) were observed after the second dose compared to the first dose.
V kliničnih študijah, s katerimi so ocenili reaktogenost pri zdravih odraslih, starih 18 ali več, ki so dobili dva 0,5 ml odmerka cepiva Pandemrix (H1N1)v, so bili deleži splošnih simptomov, ki so bili spodbujeno poročani (npr. utrujenost, glavobol, artralgija, mialgija, drgetanje, znojenje in zvišana telesna temperatura), po drugem odmerku večji kot po prvem odmerku.
In a clinical study (D-Pan-H1N1-009) in healthy children 6 months to 35 months of age (stratified in ranges from 6 to 11, 12 to 23 and 24-35 months of age) the anti-HA antibody responses 21 days after a first and a second half adult dose (i.e. 0.25 ml) or adult dose (i.e. 0.5 ml) of Pandemrix were as follows:
V klinični študiji (D-Pan-H1N1-009) pri zdravih otrocih, starih od 6 do 35 mesecev (razdeljenih v skupine od 6 do 11, 12 do 23 in 24 do 35 mesecev) so bili odzivi anti-HA protiteles 21 dni po prvem in drugem polovičnem odmerku cepiva Pandemrix za odrasle (tj. 0,25 ml) ali odmerku za odrasle (tj.
Redness Swelling Shivering Sweating Fever >38°C Fever >39°C Diarrhoea
Pordelost Oteklost Drgetanje Znojenje Zvišana telesna temperatura > 38 °C
The Day 180 seroprotection rate in the children who had received two half (0.25 ml) doses was 100% in both age groups.
Delež serološke zaščite pri otrocih, ki so prejeli dva polovična (0,25 ml) odmerka, je bil 180. dan v obeh starostnih skupinah 100 %.
In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
SESTRO, saj cepljenje ni priporočljivo ali ga je potrebno opraviti kasneje.
This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Ta adjuvans vsebuje skvalen (10,69 miligramov), DL-α-tokoferol (11,86 miligramov) in polisorbat 80 (4,86 miligramov).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for Pandemrix
IME ZDRAVILA IN POT(I) UPORABE Emulzija adjuvansa za cepivo Pandemrix i.m.
Conduct non-clinical (including mechanistic) studies in order to elucidate the role of the vaccine and its adjuvant on the association between Pandemrix and narcolepsy: - Identify T cell signature from narcoleptic patients by deep sequencing of total CD4 T cells obtained from narcolepsy patients and DQ0602-matched non-vaccinated healthy subjects and, if identified, verify if signature is found in CD4 T cells from healthy subjects after vaccination with Pandemrix or non-adjuvanted H1N1v vaccine.
- identifikacija podpisa celic T narkoleptičnih bolnikov z globokim sekvenciranjem celotnih celic T CD4, dobljenih od bolnikov z narkolepsijo, in DQ0602-usklajenih necepljenih zdravih oseb ter (v primeru uspešne identifikacije) preverjanje, ali se ta podpis nahaja tudi pri celicah T CD4 zdravih oseb po cepljenju s cepivom Pandemrix ali cepivom H1N1v brez adjuvansa
neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
• nevrološke motnje, npr. encefalomielitis (vnetje osrednjega živčevja), nevritis (vnetje živcev) in vrsta ohromitve, imenovana Guillain-Barréjev sindrom.
Very common: may affect more than 1 in 10 people
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 cepljenih oseb
unexpected severe adverse reactions, adverse events of special interest (AESI).
• Neželene učinke, ki imajo pri prijavljanju prednost, tj. smrtne in življenje ogrožajoče neželene učinke, nepričakovane hude neželene učinke, neželene učinke posebnega pomena (AESI).
Children and adolescents aged 10-17 years Dosing may be in accordance with the recommendations for adults.
Odmerjanje je lahko v skladu s priporočili za odrasle.
After 1 dose of 0.5 ml
Po 1 odmerku po 0,5 ml
Pandemrix should only be used if the recommended annual seasonal trivalent/quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see section 4.8).
Cepivo Pandemrix se sme uporabiti le, če ni na voljo priporočenih letnih sezonskih trivalentnih/štirivalentnih cepiv proti gripi, cepljenje proti (H1N1)v pa je potrebno (glejte poglavje
NA NA NA NA 21.5% 20.6% 42.1% 45.6%
Glavobol np np np np 21,5 % 20,6 % 42,1 % 45,6 %
How Pandemrix works
Kako deluje cepivo Pandemrix
Therefore, monitoring of temperature and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 6 years of age) after each dose of Pandemrix.
Zato je mlajšim otrokom (npr. do približno 6. leta starosti) po vsakem odmerku cepiva Pandemrix priporočljivo kontrolirati telesno temperaturo in uporabiti ukrepe za znižanje zvišane telesne temperature (npr.
NA NA NA NA 16.9% 17.5% 22.8% 28.1%
Mialgija np np np np 16,9 % 17,5 % 22,8 % 28,1 %
The Day 180 seroprotection rate in the children who had received two half (0.25 ml) doses was 100%.
Delež serološke zaščite pri otrocih, ki so prejeli dva polovična (0,25 ml) odmerka, je bil 180. dan
There is a further immune response to a second dose of 0.25 ml administered after an interval of three weeks.
Na drugi odmerek 0,25 ml, uporabljen po presledku treh tednov, se pojavi dodaten imunski odziv.
What you need to know before you receive Pandemrix
Kaj morate vedeti, preden boste dobili cepivo Pandemrix Cepiva Pandemrix ne smete dobiti:
There are no safety and immunogenicity data available from clinical studies with Pandemrix (H1N1)v in children aged less than 6 months.
Iz kliničnih študij cepiva Pandemrix (H1N1)v ni podatkov o varnosti in imunogenosti pri otrocih,
• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6), to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
• če se je pri vas kdaj pojavila kakršnakoli alergijska reakcija (poleg nenadne, življenje ogrožajoče alergijske reakcije) na katerokoli sestavino tega cepiva (navedeno v poglavju 6), tiomersal, jajčne in piščančje beljakovine, ovalbumin, formaldehid, gentamicinijev sulfat
Vasculitis with transient renal involvement 1frequency based on estimated attributable risk from epidemiological studies in several European countries (see section 4.4) 2Reported in patients with narcolepsy and as a temporary event following vaccination
Žilne bolezni zelo redki vaskulitis s prehodno prizadetostjo ledvic 1 Pogostnost temelji na ocenjenem pripisljivem tveganju iz epidemioloških študij v več evropskih državah (glejte poglavje 4.4).
2percentage of vaccinees who, if initially seronegative reach an antibody titre ≥32 1/DIL after vaccination or, if initially seropositive reach an antibody titre ≥ 4-fold the pre-vaccination antibody titre
2odstotek cepljenih oseb, ki so po cepljenju dosegle titer protiteles ≥ 32 1/DIL (razmerje razredčenja), če so bile uvodoma seronegativne, ali ki so dosegle ≥ 4-kraten titer protiteles kot je bil pred cepljenjem, če so bile uvodoma seropozitivne
In a clinical study that evaluated reactogenicity in children aged 6 to 35 months who received either two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) (21 days apart) of Pandemrix (H1N1)v there was an increase in injection site reactions and general symptoms after the second dose compared to the first dose particularly in rates of axillary fever (>38°C).
Vklinični študiji, s katero so ocenili reaktogenost pri otrocih, starih od 6 do 35 mesecev, ki so dobili ali dva 0,25 ml odmerka (polovični odmerek za odrasle) ali dva 0,5 ml odmerka (odmerek za odrasle) (21 dni narazen) cepiva Pandemrix (H1N1)v, so opazili več reakcij na mestu injiciranja in splošnih simptomov po drugem odmerku v primerjavi s prvim odmerkom, zlasti deleža zvišane aksilarne temperature (> 38 °C).
23.3% 17.9% 15.1% 28.8% NA NA NA NA
23,3 % 17,9 % 15,1 % 28,8 % np np np np
Pandemrix suspension and emulsion for emulsion for injection Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Pandemrix suspenzija in emulzija za emulzijo za injiciranje cepivo proti gripi (H1N1)v z delci virionov, inaktivirano (z adjuvansom)
Very common Headache Uncommon Paraesthesia, dizziness
Bolezni živčevja zelo pogosti glavobol občasni parestezije, omotica
If they persist, CONSULT YOUR DOCTOR.
POSVETUJTE Z ZDRAVNIKOM.
• Pain and swelling at the injection site
• bolečina in oteklina na mestu injiciranja,
Very rare: may affect up to 1 in 10,000 people
Zelo redki: pojavijo se lahko pri največ 1 od 10.000 cepljenih oseb
NA NA NA NA 15.4% 14.3% 14.0% 22.8%
Artralgija np np np np 15,4 % 14,3 % 14,0 % 22,8 %
Rare: may affect up to 1 in 1,000 people
Redki: pojavijo se lahko pri največ 1 od 1.000 cepljenih oseb
How to store Pandemrix
Kako uporabljati cepivo Pandemrix
Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Vsebina: Adjuvans AS03, sestavljen iz skvalena (10,69 miligramov), DL-α-tokoferola (11,86 miligramov) in polisorbata 80 (4,86 miligramov).
5all subjects seronegative prior to vaccination anti-HA
5 Vsi preiskovanci so bili pred cepljenjem seronegativni.
Talk to your doctor or nurse before you receive Pandemrix:
Opozorila in previdnostni ukrepi Preden dobite cepivo Pandemrix, se posvetujte s svojim zdravnikom ali z medicinsko sestro:
Injection site reactions (such as inflammation, mass, ecchymosis)
Splošne težave in spremembe na mestu aplikacije reakcije na mestu injiciranja (na primer vnetje, masa, ekhimoze)
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
Anafilaktična reakcija v anamnezi (tj. življenjsko nevarna) na katerokoli sestavino cepiva ali ostanke v sledeh (jajčne in piščančje beljakovine, ovalbumin, formaldehid, gentamicinijev sulfat ali natrijev deoksiholat).
STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose *Antigen: A/California/07/2009 (H1N1) derived strain used NYMCX-179A
razcepljen virus influence, inaktiviran, ki vsebuje antigene*, ki ustrezajo 3,75 mikrogramom hemaglutinina/odmerek *Antigen: uporabljen sev NYMC X-179A pridobljen iz seva A/California/07/2009 (H1N1)
Month 12 N=28
12. mesec n=28
Month 6 N=22
6. mesec n=22
Contents of the pack and other information
Shranjevanje cepiva Pandemrix Vsebina pakiranja in dodatne informacije
The vaccine should be administered in accordance with the recommended posology (see section 3 “How Pandemrix is given”).
Po mešanju je količina cepiva Pandemrix v viali vsaj 5 ml. Cepivo je treba uporabiti v skladu s priporočenim odmerjanjem (glejte poglavje 3 "Kako uporabljati cepivo Pandemrix").
Serum neutralising antibody
Nevtralizi rajoča protitelesa v serumu
In two clinical studies in which children aged 3 to 9 years old received two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) of Pandemrix, the anti-HA antibody responses 21 days after the first and the second dose were as follows:
V dveh kliničnih študijah, v katerih so otroci, stari od 3 do 9 let dobili dva 0,25 ml odmerka (polovični odmerek za odrasle) ali dva 0,5 ml odmerka (odmerek za odrasle) cepiva Pandemrix, so bili odzivi anti-HA protiteles 21 dni po prvem in drugem odmerku naslednji:
Very common Swelling and pain at the injection site, fatigue, shivering
Splošne težave in spremembe na mestu aplikacije zelo pogosti oteklost in bolečina ne mestu injiciranja,
Month 12 N=31
12. mesec n=31
• Redness and itching at the injection site
• pordelost in srbenje na mestu injiciranja,
Month 6 N=18
6. mesec n=18
Month 12 N=7
12.mesec n=7
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
1 Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HIhaemagglutination inhibition) ≥1:40
Redness and pruritus at the injection site, fever Uncommon induration and warmth at the injection site, influenza like illness, malaise Post-marketing experience with Pandemrix (H1N1)v Immune system disorders
utrujenost, drgetanje pogosti pordelost in srbenje na mestu injiciranja, zvišana telesna temperatura občasni zatrdelo in toplo mesto injiciranja, gripi podobna bolezen, splošno slabo počutje
20.0% 17.9% 15.1% 32.7% NA NA NA NA
Izguba apetita 20,0 % 17,9 % 15,1 % 32,7 % np np np np
Month 6 N=15
6. mesec n=15
Full dose (D-Pan-H1N1-010)
Polni odmerek (D-Pan-H1N1-010)
anti-HA antibody Immune response to A/California/7/2009 (H1N1)v-like >80 years Month 12 after 2 doses of 0.5 ml
Imunski odziv proti A/California/7/2009 (H1N1)vpodobnemu sevu >80 let 12. mesec po 2 odmerkih po 0,5 ml
Month 6 N=17
6. mesec n=17
1antigenically similar to A/California/7/2009 (H1N1)v-like
1antigensko podoben A/California/7/2009 (H1N1)v-podobnemu sevu
Adverse reactions reported are listed per dose according to the following frequency: Very common (≥1/10)
Opisani neželeni učinki so navedeni na odmerek po naslednjih skupinah pogostnosti:
Month 6 after 1 dose of 0.5 ml
6. mesec po 1 odmerku 0,5 ml
Total enrolled subjects N=25
Skupno vklju čeni preiskovanci n=25
Total enrolled subjects N=33
Skupno vklju čeni preiskovanci n=33
In children aged 6-35 months who received two doses of 0.25 ml of Pandemrix (H1N1), there was an increase in reports of pain, redness and swelling at the injection site as well as fever (>38°C), drowsiness, irritability and loss of appetite after the second dose compared to the first dose.
(H1N1)v, so več poročali o bolečini, rdečini in oteklosti na mestu injiciranja ter o zvišani telesni temperaturi (> 38 °C), zaspanosti, razdražljivosti in izgubi apetita po drugem odmerku v primerjavi s prvim odmerkom.
Seroconversio n rate2
Delež serokonverz ije2
Adult dose5 (D-Pan-H1N1-010)
Odmerek za odrasle5 (D-Pan-H1N1-010)
Immune response to A/Netherlands/602/9 (H1N1)v-like1 After 2 doses of 0.5 ml
Imunski odziv proti A/Netherlands/602/9 (H1N1)v-podobnemu sevu1 Po 2 odmerkih po 0,5 ml
Immune response to A/California/7/2009 (H1N1)v-like >80 years
Imunski odziv proti A/California/7/2009 (H1N1)v-podobnemu sevu >80 let
Total enrolled subjects N=15
Skupno vklju čeni preiskovanci n=15
A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms** per 0.5 ml dose *propagated in eggs **expressed in microgram haemagglutinin
uporabljenemu sevu NYMC X-179A pridobljenemu iz seva A/California/07/2009 (H1N1) 3,75°mikrogramov** na 0,5 ml odmerek
Your doctor or nurse will administer the vaccine in accordance with official recommendations.
V skladu z uradnimi priporočili vas bo cepil zdravnik ali medicinska sestra.
Day 21 N=18
21. dan n=18
Month 6 N=13
6. mesec n=13
Total enrolled subjects N=24
Skupno vključe ni preiskovanci n =24
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 anti-HA antibody
haemagglutination inhibition) ≥1:40 anti-HA protitelesa
In clinical studies that evaluated the reactogenicity in children 10 to 17 years of age who received either two 0.5 ml doses (adult dose) or two 0.25 ml doses (half adult dose) (21 days apart) of Pandemrix (H1N1)v, the per-dose frequency of the following adverse reactions was as shown in the table:
V kliničnih študijah, s katerimi so ocenili reaktogenost pri otrocih, starih od 10 do 17 let, ki so dobili ali dva 0,5 ml odmerka (odmerek za odrasle) ali dva 0,25 ml odmerka (polovični odmerek za odrasle) (21 dni narazen) cepiva Pandemrix (H1N1)v, je bila pogostnost naslednjih neželenih učinkov na odmerek, kot je prikazano v preglednici:
Vaccine Response
Delež odziva na cepivo2
Month 12 N=13
12. mesec n=13
Total enrolled subjects N=40
Skupno vklju čeni preiskovanci n=40
• Severe stabbing or throbbing pain along one or more nerves
• hujša zbadajoča ali kljuvajoča bolečina vzdolž enega ali več živcev, • znižanje števila trombocitov s posledičnim pojavom krvavitev ali modric.
In clinical studies that evaluated reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) (21 days apart) of Pandemrix (H1N1)v, the per-dose frequency of the following adverse reactions was as shown in the table:
V kliničnih študijah, s katerimi so ocenili reaktogenost pri otrocih, starih od 3 do 5 in od 6 do 9 let, ki so dobili ali dva 0,25 ml odmerka (polovični odmerek za odrasle) ali dva 0,5 ml odmerka (odmerek za odrasle) (21 dni narazen) cepiva Pandemrix (H1N1)v, je bila pogostnost naslednjih neželenih učinkov na odmerek, kot je prikazano v preglednici: