FrancophonIA/ELRC3.0 huggingface dataset:
English: • Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems)
Slovenian: • vaskulitis (vnetje žil, ki lahko povzroči izpuščaje na koži, bolečine v sklepih in težave z ledvicami),
English: In adults 18 to 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (87.8%), fatigue (32.9%), headache (28.1%), arthralgia (17.9%), myalgia (30.0%), shivering (19.4%), injection site swelling (11.5%) and sweating (11.3%).
Slovenian: Pri odraslih v starosti od 18 do 60 let so bili najpogosteje zabeleženi neželeni učinki po cepljenju bolečina na mestu injiciranja (87,8 %), utrujenost (32,9 %), glavobol (28,1 %), artralgija (17,9 %), mialgija (30,0 %), drgetanje (19,4 %), oteklost na mestu injiciranja (11,5 %) in znojenje (11,3 %).
English: • Reactions at the injection site such as pain, redness, bruising, swelling and heat (inflammation),
Slovenian: • reakcije na mestu injiciranja, npr. bolečine, pordelost, podplutba, oteklost in toplota (vnetje), trda bula (masa).
English: One dose of 0.25 ml at an elected date.
Slovenian: En 0,25 ml odmerek na izbrani datum.
English: - If you get any of side effects, talk to your doctor.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
English: 5according to protocol
Slovenian: 5 Glede na protokol.
English: Pandemrix should under no circumstances be administered intravascularly.
Slovenian: Cepiva Pandemrix se v nobenem primeru ne sme injicirati v žilo.
English: Six months after the first dose, the seroprotection rate was as follows:
Slovenian: Šest mesecev po prvem odmerku je bil delež serološke zaščite naslednji:
English: In subjects > 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (59.0%), myalgia (20.6%), fatigue (17.9%), headache (17.6%) and arthralgia (14.3%).
Slovenian: Pri preiskovancih, starejših od 60 let, so bili najpogosteje zabeleženi neželeni učinki po cepljenju bolečina na mestu injiciranja (59,0 %), mialgija (20,6 %), utrujenost (17,9 %), glavobol (17,6 %) in artralgija (14,3 %).
English: Adult dose
Slovenian: Odmerek za odrasle
English: Pandemrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Slovenian: Cepivo Pandemrix vsebuje konzervans tiomersal, ki lahko povzroči alergijsko reakcijo.
English: Children aged less than 6 months
Slovenian: starih manj kot 6 mesecev.
English: 5.0% 5.4% 1.9% 5.8% NA NA NA NA
Slovenian: 5,0 % 5,4 % 1,9 % 5,8 % np np np np
English: • if you have a bleeding problem or bruise easily.
Slovenian: • če imate kakšno motnjo strjevanja krvi ali ste nagnjeni k podplutbam.
English: Non-clinical data obtained with the mock-up vaccine using a H5N1 vaccine strain reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period).
Slovenian: Predklinični podatki, pridobljeni z modelnim cepivom z uporabo seva H5N1, na osnovi običajnih študij farmakološke varnosti, akutne toksičnosti in toksičnosti pri ponavljajočih se odmerkih, lokalne tolerance, plodnosti pri samicah, embrio-fetalne in postnatalne toksičnosti (do konca obdobja laktacije) ne kažejo posebnega tveganja za človeka.
English: Fever (>39°C) axillary
Slovenian: Zvišana telesna temperatura (> 39 °C) aksilarno
English: No data are available in children aged less than 6 months.
Slovenian: Otroci, mlajši od 6 mesecev Podatkov ni na voljo.
English: Prophylaxis of influenza caused by A (H1N1)v 2009 virus.
Slovenian: Preprečevanje gripe, ki jo povzroča virus A (H1N1)v 2009.
English: Half adult dose4
Slovenian: Polovični odmerek za odrasle4
English: The vial should be shaken prior to each administration and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Slovenian: Vsako posamezno vialo je potrebno pretresti in pregledati, ali morda vsebuje tuje delce in/ali je nenormalnega videza.
English: • Feeling sick, diarrhoea, vomiting, stomach pain
Slovenian: • siljenje na bruhanje, driska, bruhanje, bolečine v trebuhu.
English: 10-17 years
Slovenian: 10 do 17 let
English: Narcolepsy can occur with or without sudden muscle weakness that can cause falls (a condition called cataplexy).
Slovenian: Narkolepsija se lahko pojavi skupaj z nenadno mišično šibkostjo ali brez nje; če se pojavi skupaj z nenadno mišično šibkostjo, lahko povzroči padce (to stanje imenujemo katapleksija).
English: 3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
Slovenian: 3Faktor serokonverzije: razmerje med geometrično sredino (GMT - geometric mean titre) titra po cepljenju in GMT titra pred cepljenjem.
English: Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a 1 ml syringe for injection and administered intramuscularly.
Slovenian: Vsak odmerek cepiva z 0,5 ml (polni odmerek) ali z 0,25 ml (polovični odmerek) izvlecite v 1ml injekcijsko brizgo in injicirajte intramuskularno.
English: A dose (0.5 ml) of the vaccine will be given.
Slovenian: Dobili boste en odmerek (0,5 ml) cepiva.
English: Data obtained on co-administration of Pandemrix (H1N1)v with non-adjuvanted seasonal influenza vaccine (Fluarix, a split virion vaccine) in healthy adults aged over 60 years did not suggest any significant interference in the immune response to Pandemrix (H1N1)v. The immune response to Fluarix was satisfactory.
Slovenian: Podatki, dobljeni pri sočasni uporabi cepiva Pandemrix (H1N1)v s cepivom proti sezonski gripi brez adjuvansa (Fluarix, cepivo z delci virionov) pri zdravih odraslih, starejših od 60 let, ne kažejo pomembnega vpliva na imunski odziv na cepivo Pandemrix (H1N1)v. Imunski odziv na cepivo Fluarix je bil zadovoljiv.
English: Therefore the data indicate that Pandemrix may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Slovenian: Podatki torej kažejo, da je mogoče cepivo Pandemrix uporabiti hkrati s cepivi proti sezonski gripi brez adjuvansa (vendar je cepivi treba injicirati v različni okončini).
English: A minor infection such as a cold should not be a problem, but your doctor or nurse will advise whether you could still be vaccinated with Pandemrix.
Slovenian: Blažja okužba, npr. prehlad, ne predstavlja težave, vendar se pred cepljenjem s cepivom Pandemrix o tem vseeno posvetujte s svojim zdravnikom.
English: Angioedema, generalised skin reactions, urticaria
Slovenian: Bolezni kože in podkožja angioedem, generalizirane kožne reakcije,
English: All subjects received two doses of 0.5 ml 21 days apart, except in study D-Pan H1N1-008, in which half of the subjects received only one dose of 0.5 ml.
Slovenian: Vse osebe so prejele dva odmerka 0,5 ml v presledku 21 dni, razen v študiji D-Pan H1N1-008, v kateri je pol oseb prejelo le en odmerek 0,5 ml. Odzivi protiteles na antiHA so bili naslednji:
English: 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 sections 4.4 and 4.8).
Slovenian: Cepivo Pandemrix se lahko uporabi le, če ni na voljo priporočenih letnih sezonskih trivalentnih/štirivalentnih cepiv proti gripi, potrebno pa je cepljenje proti (H1N1)v (glejte poglavji 4.4 in 4.8).
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
Slovenian: Bolezni živčevja redki nevralgija zelo redki nevrološke motnje, na primer encefalomielitis, nevritis in GuillainBarréjev sindrom
English: • Generalised skin reactions including facial swelling and urticaria (hives)
Slovenian: • generalizirane kožne reakcije vključno z otekanjem obraza in urtikarijo (koprivnico);
English: D-Pan H1N1-008 21 days after 1st dose 21 days after 2nd dose 21 days after 1st dose 21 days after 2nd dose
Slovenian: D-Pan H1N1-008 21 dni po 1. odmerku 21 dni po 2. odmerku 21 dni po 1. odmerku 21 dni po 2. odmerku Skupno vključeni preiskovanci n=60 [95% IZ]
English: The anti-HA antibody responses in healthy subjects aged >60 years who received either one or two doses of 0.5 ml 21 days apart were as follows:
Slovenian: Odzivi anti-HA protiteles pri zdravih preiskovancih, starejših od 60 let, ki so prejeli bodisi en ali dva 0,5 ml odmerka cepiva v razmaku 21 dni, so bili naslednji:
English: What Pandemrix is and what it is used for
Slovenian: Kaj je cepivo Pandemrix in za kaj ga uporabljamo Kaj je cepivo Pandemrix in za kaj ga uporabljamo
English: The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)vlike strains.
Slovenian: Pričakuje se, da cepivo ščiti le pred gripo, ki jo povzročijo sevi, podobni A/California/07/2009
English: 20.0% 26.8% 18.9% 26.9% NA NA NA NA
Slovenian: 20,0 % 26,8 % 18,9 % 26,9 % np np np np
English: 71-80 years 21 days after 1st dose 21 days after 2nd dose 21 days after 1st dose 21 days after 2nd dose
Slovenian: 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]
English: 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.
Slovenian: 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.
English: CI]
Slovenian: IZ]
English: Pandemrix contains thiomersal
Slovenian: Cepivo Pandemrix vsebuje tiomersal
English: NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Pandemrix
Slovenian: IME ZDRAVILA Emulzija za emulzijo za injiciranje za cepivo Pandemrix
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Month N=24
Slovenian: mesec n=24
English: • Swollen glands in the neck, armpit or groin
Slovenian: • otekle bezgavke na vratu, pod pazduhami ali v dimljah,
English: 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;
Slovenian: 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;
English: 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.
Slovenian: 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 %.
English: Total enrolled subjects N=120
Slovenian: Skupno vključeni preiskovanci n=120
English: Post-marketing experience with trivalent seasonal influenza vaccines Blood and lymphatic system disorders
Slovenian: Izkušnje s trivalentnimi sezonskimi cepivi proti gripi med obdobjem trženja
English: 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.
Slovenian: 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.
English: • Tingling or numbness of the hands or feet
Slovenian: • mravljinčenje ali odrevenelost v rokah ali nogah, • nespečnost,
English: Suspension and emulsion for emulsion for injection
Slovenian: suspenzija in emulzija za emulzijo za injiciranje
English: Pandemrix contains sodium and potassium
Slovenian: Cepivo Pandemrix vsebuje natrij in kalij
English: • A long-term condition with excessive daytime sleepiness (narcolepsy), with or without sudden weakness (cataplexy), which may lead to falls without loss of consciousness
Slovenian: • dolgotrajna motnja s čezmerno zaspanostjo čez dan (narkolepsija), z nenadno mišično šibkostjo
English: • Fits due to fever
Slovenian: • krči zaradi zvišane telesne temperature;
English: Very rare (<1/10,000)
Slovenian: Zelo pogosti (≥ 1/10)
English: NA NA NA NA 27.7% 20.6% 35.1% 49.1%
Slovenian: Utrujenost np np np np 27,7 % 20,6 % 35,1 % 49,1 %
English: See section 5.1 regarding immune responses to one and two doses of Pandemrix (H1N1)v, including antibody levels after 6 and 12 months.
Slovenian: 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.
English: Before the vaccine is mixed:
Slovenian: Pred premešanjem cepiva
English: Clinical trials Blood and lymphatic system disorders
Slovenian: Klinična preskušanja Bolezni krvi in limfatičnega sistema občasni limfadenopatija
English: Gastrointestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Slovenian: Bolezni prebavil pogosti gastrointestinalni simptomi (na primer driska, bruhanje, bolečine v trebuhu,
English: 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.
Slovenian: 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).
English: Month N=10
Slovenian: mesec n=10
English: There are no data on co-administration of Pandemrix with other vaccines.
Slovenian: Podatkov o sočasni uporabi cepiva Pandemrix z drugimi cepivi ni.
English: 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).
Slovenian: 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).
English: There is no information on administration of Pandemrix with other vaccines.
Slovenian: O uporabi cepiva Pandemrix z drugimi cepivi ni podatkov.
English: Please consult the Product Information of Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted).
Slovenian: Glejte informacije o cepivu Cepivo proti pandemski gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom).
English: Half adult dose
Slovenian: Polovični odmerek za odrasle
English: N=60 N=56 N=53 N=52 N=65 N=63 N=57 N=57
Slovenian: Po 2. odmerku n=34 n=32 n=30 n=28 n=15 n=15 n=14 n=14
English: NA NA NA NA 13.8% 7.9% 15.8% 14.0%
Slovenian: Prebavni np np np np 13,8 % 7,9 % 15,8 % 14,0 %
English: Redness Swelling Fever (>38°C) axillary
Slovenian: Zvišana telesna temperatura (> 38 °C) aksilarno
English: 6-9 years
Slovenian: Od 6 do 9 let
English: 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.
Slovenian: 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.
English: 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:
Slovenian: 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.
English: Redness Swelling Shivering Sweating Fever >38°C Fever >39°C Diarrhoea
Slovenian: Pordelost Oteklost Drgetanje Znojenje Zvišana telesna temperatura > 38 °C
English: The Day 180 seroprotection rate in the children who had received two half (0.25 ml) doses was 100% in both age groups.
Slovenian: Delež serološke zaščite pri otrocih, ki so prejeli dva polovična (0,25 ml) odmerka, je bil 180. dan v obeh starostnih skupinah 100 %.
English: In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
Slovenian: SESTRO, saj cepljenje ni priporočljivo ali ga je potrebno opraviti kasneje.
English: This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Slovenian: Ta adjuvans vsebuje skvalen (10,69 miligramov), DL-α-tokoferol (11,86 miligramov) in polisorbat 80 (4,86 miligramov).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for Pandemrix
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Emulzija adjuvansa za cepivo Pandemrix i.m.
English: 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.
Slovenian: - 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
English: neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
Slovenian: • nevrološke motnje, npr. encefalomielitis (vnetje osrednjega živčevja), nevritis (vnetje živcev) in vrsta ohromitve, imenovana Guillain-Barréjev sindrom.
English: Very common: may affect more than 1 in 10 people
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 cepljenih oseb
English: unexpected severe adverse reactions, adverse events of special interest (AESI).
Slovenian: • Neželene učinke, ki imajo pri prijavljanju prednost, tj. smrtne in življenje ogrožajoče neželene učinke, nepričakovane hude neželene učinke, neželene učinke posebnega pomena (AESI).
English: Children and adolescents aged 10-17 years Dosing may be in accordance with the recommendations for adults.
Slovenian: Odmerjanje je lahko v skladu s priporočili za odrasle.
English: After 1 dose of 0.5 ml
Slovenian: Po 1 odmerku po 0,5 ml
English: 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).
Slovenian: 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
English: NA NA NA NA 21.5% 20.6% 42.1% 45.6%
Slovenian: Glavobol np np np np 21,5 % 20,6 % 42,1 % 45,6 %
English: How Pandemrix works
Slovenian: Kako deluje cepivo Pandemrix
English: 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.
Slovenian: 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.
English: NA NA NA NA 16.9% 17.5% 22.8% 28.1%
Slovenian: Mialgija np np np np 16,9 % 17,5 % 22,8 % 28,1 %
English: The Day 180 seroprotection rate in the children who had received two half (0.25 ml) doses was 100%.
Slovenian: Delež serološke zaščite pri otrocih, ki so prejeli dva polovična (0,25 ml) odmerka, je bil 180. dan
English: There is a further immune response to a second dose of 0.25 ml administered after an interval of three weeks.
Slovenian: Na drugi odmerek 0,25 ml, uporabljen po presledku treh tednov, se pojavi dodaten imunski odziv.
English: What you need to know before you receive Pandemrix
Slovenian: Kaj morate vedeti, preden boste dobili cepivo Pandemrix Cepiva Pandemrix ne smete dobiti:
English: There are no safety and immunogenicity data available from clinical studies with Pandemrix (H1N1)v in children aged less than 6 months.
Slovenian: Iz kliničnih študij cepiva Pandemrix (H1N1)v ni podatkov o varnosti in imunogenosti pri otrocih,
English: • 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.
Slovenian: • 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