natgillin/translations-raw huggingface dataset:
In addition, the side effects listed below have occurred in the days or weeks after vaccination with adjuvanted and non-adjuvanted vaccines given routinely every year to prevent flu.
Dodatno so se učinki, opisani v nadaljevanju, pojavili v dnevih in tednih po cepljenju s cepivi, ki se uporabljajo vsako leto za preprečevanje gripe in so vsebovala adjuvans ali pa ne. Ti neželeni učinki se lahko pojavijo po uporabi cepiva Focetria.
Very common reactions reported in children and adolescents 3 to 17 years of age: Pain, induration and erythema, malaise, myalgia, headache and fatigue.
Zelo pogosti neželeni učinki pri otrocih in mladostnikih, starih od 3 do 17 let: bolečina, zatrdlina in eritem, utrujenost, mialgija, glavobol in slabotnost.
Fertility An animal study with H5N1 mock-up vaccine did not indicate reproductive toxicity (see section 5.3).
Študija modelnega cepiva H5N1 na živalih ni pokazala vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
Pre-filled syringe:
Napolnjena injekcijska brizga:
Skin and subcutaneous tissue disorders Common: sweating Uncommon: urticaria Rare: eye swelling
Bolezni kože in podkožja Pogosti: potenje Občasni: urtikarija Redki: otekanje oči
METHOD OF ADMINISTRATION Gently shake before use.
POSTOPE UPORABE Pred uporabo nežno pretresite.
(Manufacturer responsible for final filtration of monovalent pooled harvest): Novartis Vaccines and Diagnostics S.r.l.
(Izdelovalec, odgovoren za končno filtriranje monovalentnih zbranih pridelkov): Novartis Vaccines and Diagnostics S.r.l.
See section 4.4 for special warnings and special precautions for use.
Za posebna opozorila in previdnostne ukrepe glejte poglavje 4.4.
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 zamaškom na batu (bromobutilna guma).
There is no information on administration of the vaccine Focetria with any other vaccines.
O uporabi cepiva Focetria z drugimi cepivi ni podatkov.
Very common: pain, induration and erythema, myalgia, headache, sweating, malaise and fatigue
Zelo pogosti: bolečina, zatrdlina in rdečina, mialgija, glavobol, znojenje, slabo počutje in utrujenost.
Generalised skin reactions including itching, urticaria (hives), rash or swelling of the skin and mucous membranes.
Generalizirana kožna reakcija vključno s srbenjem, urtikarijo (koprivico), izpuščajem ali oteklino kože in sluznice.
Children aged 6 months to 35 months:
Otroci, stari od 6 do 35 mesecev:
Gently shake the multidose vial each time before withdrawing a dose (0.5 ml) of the vaccine into a syringe.
Večodmerno vialo pred prenosom odmerka (0,5 ml) cepiva v brizgo nežno pretresite.
Fever ≥38°C to 38.9°C
Zvišana telesna temperatura ≥38 °C/≥38,9 °C
Focetria H1N1v
Cepivo Focetria H1N1v
Children and adolescents aged 3-17 years:
Otroci in mladostniki stari 3-17 let:
Therefore, in view of available data regarding the use of Focetria during pregnancy, the PRAC considered that changes to the product information were warranted.
Odbor PRAC meni, da so z vidika razpoložljivih podatkov o uporabi cepiva Focetria med nosečnostjo te spremembe informacij o zdravilu potrebne.
Focetria can be given at the same time as non-adjuvanted seasonal influenza vaccines, with injections made into separate limbs.
Cepivo Focetria je mogoče dati hkrati s sezonskimi cepivi proti gripi, ki ne vsebujejo adjuvansa, pri čemer se za cepljenje uporabljata nasprotni okončini.
General side effects reported very commonly in the 6 months-35 months of age group per dose were irritability, unusual crying, sleepiness, diarrhoea and change in eating habits.
Zelo pogosto opaženi neželeni učinki na odmerek v starostni skupini od 6 do 35 mesecev so bili razdražljivost, neobičajen jok, zaspanost, driska in sprememba prehranjevalnih navad.
Adverse reactions in the week following vaccination from 80 infants 6-11 months old and 82 toddlers 12-35 months old, receiving the 7.5 µg formulation were reported as follows:
Poročali so o naslednjih neželenih učinkih v tednu po cepljenju pri 80 dojenčkih, starih 6-11 mesecev, in 82 malčkih, starih 12-35 mesecev, ki so prejeli formulacijo 7,5 µg:
When Focetria is given for the first dose, it is recommended that Focetria (and not another vaccine against H1N1v) be given for the complete vaccination course.
Priporočljivo je, da osebe, ki so prejele prvi odmerek cepiva Focetria (ne drugega cepiva proti virusu H1N1v), dokončajo cepljenje s cepivom Focetria.
Data in infants and toddlers 6-35 months of age suggest a slight decrease in reactogenicity after the second dose, with no increase in rates of fever.
Podatki pri dojenčkih in malčkih, starih 6-35 mesecev, kažejo rahlo zmanjšanje reaktogenosti po drugem odmerku, brez zvišanja stopnje zvišane telesne temperature.
Headache, dizziness, drowsiness, fainting.
Glavobol, omotičnost, zaspanost, omedlevica.
Very common reactions reported in 233 infants and toddlers 6 to 35 months of age: Tenderness, erythema, irritability, unusual crying, sleepiness, diarrhoea and change in eating habits.
Zelo pogosti neželeni učinki pri 233 dojenčkih in malčkih, starih 6 do 35 mesecev: občutljivost, rdečina, razdražljivost, neobičajen jok, zaspanost, driska in sprememba prehranjevalnih navad.
H1N1v to healthy children and adolescents aged 6 months-17 years and to healthy adults,
Focetria (H1N1) pri zdravih otrocih in mladostnikih v starosti 6 mesecev-17 let in zdravih odraslih oseb, vključno s starostniki.
Immune response to Focetria H1N1v
Imunski odziv na cepivo Focetria H1N1v
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 10-DOSE VIAL
PODATKI NA ZUNANJI OVOJNINI KARTONASTA ŠKATLA ZA VIALO Z DESETIMI ODMERKI
Data in children and adolescents 3-17 years suggest a slight decrease in reactogenicity after the second dose, with no increase in rates of fever.
Podatki pri otrocih in mladostnikih, starih med 3-17 let, kažejo na majhno znižanje reaktogenosti po drugem odmerku, brez zvišanja stopnje zvišane telesne temperature.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR 10-DOSE VIAL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH OZNAKA ZA VIALO Z DESETIMI ODMERKI
Rare (affects 1 to 10 users in 10,000): Convulsion, eye swelling and anaphylaxis
Redki (pojavijo se pri 1 do 10 cepljenih osebah od 10.000 cepljenih oseb): krči, zabuhlost oči in anafilaksa
Most of the reactions were mild in nature and of short duration.
Večinoma so bili neželeni učinki kratkotrajni in blagi.
Very commonly reported reactions in both children and adolescents were pain, hardening of the skin at the injection site, injection site redness, generally feeling unwell, muscle ache, headache and fatigue.
Pri otrocih in mladostnikih sta bila zelo pogosta neželena učinka bolečina, otrdlina kože na mestu injiciranja, pordelost na mestu injiciranja, splošno slabo počutje, bolečina mišic, glavobol in utrujenost.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR SYRINGE
PODATKI NA ZUNANJI OVOJNINI KARTONASTA ŠKATLA ZA BRIZGO
- If any of the side effects gets serious, talk to your doctor.
- Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
Total N=88
Skupno n = 88
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/California/07/2009 (H1N1)-derived strain used NYMC X-181
Površinski virusni antigeni (hemaglutinin in nevraminidaza) * seva: NYMC X-181 pridobljenega iz seva A/California/07/2009 (H1N1)
Please consult the Product Information of: Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
Glejte informacije o cepivu: Cepivo proti pandemski gripi (H5N1) s površinskimi antigeni, inaktivirano, z adjuvansom.
1 x single dose of 0.5 ml pre-filled syringe 10 x single dose of 0.5 ml pre-filled syringes
1 napolnjena injekcijska brizga z enkratnim odmerkom 0,5 ml 10 napolnjenih injekcijskih brizg z enkratnim odmerkom 0,5 ml
Adverse reactions in the week following vaccination from 87 children 3-8 years old and 95 children and adolescents 9-17 years old receiving the 7.5 µg formulation were reported as follows:
Poročali so o naslednjih neželenih učinkih v tednu po cepljenju za 87 otrok, starih med 3-8 let in za 95 otrok in mladostnikov, starih med 9-17 let, ki so prejemali obliko s 7,5 µg :
Among the adolescents the very common events were: sweating, nausea and chills.
Med mladostniki so bili zelo pogosti neželeni učinki: potenje, slabost in mrazenje.
Take special care with Focetria:
Bodite posebno pozorni pri uporabi cepiva Focetria
Breast-feeding Focetria may be administered to lactating women.
Dojenje S cepivom Focetria se lahko cepi doječe ženske.
Swollen lymph nodes, palpitations, weakness, pain in the extremities and cough.
Otekle bezgavke, palpitacije, slabotnost, bolečina okončin in kašelj.
“Possible side effects” may affect the ability to drive or use machines.
Nekateri učinki, navedeni v poglavju 4 „Možni neželeni učinki“ lahko vplivajo na sposobnost upravljanja vozil in strojev.
Total N=57
Skupno n = 57
The side effects listed below have occurred with Focetria in clinical studies in adults, including the elderly:
Neželeni učinki, opisani v nadaljevanju, so se pojavili po cepljenju odraslih oseb in starostnikov s cepivom Focetria v kliničnih študijah:
What Focetria contains
Kaj vsebuje cepivo Focetria
Seroconversion or Significant Increase (95% CI) * measured by HI assay ** geometric mean ratios of HI
Serokonverzija ali značilno zvečanje (95-% IZ) * merjeno s testom HI ** razmerja geometrične srednje vrednosti (GMR) HI
GMR (95% CI) Seroconversion or Significant Increase (95% CI)
Stopnja serološke zaščite (95-% IZ) GMR (95-% IZ) Serokonverzija ali značilno zvečanje (95-% IZ)
Cases of convulsion with and without fever have been reported in subjects vaccinated with Focetria.
Pri osebah, cepljenih s cepivom Focetria, so poročali o primerih konvulzij s povišano telesno temperature ali brez nje.
Seronegative at baseline N=51
Seronegativni ob začetku spremljanja n = 51
Seronegative at baseline N=37
Seronegativni ob začetku spremljanja n = 37
PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe.
FARMACEVTSKA OBLIKA suspenzija za injiciranje v napolnjeni injekcijski brizgi mlečno bela tekočina
Seronegative at baseline N=48
Seronegativni ob začetku spremljanja n = 48
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Focetria injection
IME ZDRAVILA IN POT(I) UPORABE Focetria injekcija cepivo proti gripi H1N1v intramuskularna uporaba
Respiratory disorders
Bolezni živčevja
Clinical trials with Focetria H1N1v
Klinična preskušanja s cepivom Focetria H1N1v
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of Focetria (these are listed at the end of the leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB).
• če ste imeli nenadno, življenjsko ogrožajočo alergijsko reakcijo na katero koli sestavino cepiva Focetria (ki so navedene na koncu navodila za uporabo) ali katere koli ostanke v sledovih, kot sledi: jajčne in kokošje beljakovine, ovalbumin, formaldehid, kanamicin- in neomicinsulfat (antibiotika) in cetiltrimetilamonijev bromid (CTAB).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH OZNAKA ZA BRIZGO
There are no data on co-administration of Focetria with other vaccines.
Podatkov o sočasni uporabi cepiva Pandemrix z drugimi cepivi ni.
Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 793 to 1065 (N=88) and an increase in GMT from 522 to 870 in children who were seronegative at baseline (N=51).
Podatki o odzivu na drugi odmerek po 3-tedenskem premoru so pokazali zvišanje splošnega GMT s 793 na 1065 (n = 88) in zvišanje GMT od 522 na 870 pri otrocih, ki so bili ob izhodišču seronegativni (n = 51).
• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal (only for the multidose vial presentation), to egg and, chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB).
• če ste imeli alergijsko reakcijo, ki ni bila nenadna in življenjsko ogrožajoča, na katero koli sestavino cepiva, tiomersal (samo za pakiranje v večodmernih vsebnikih), jajčne in kokošje beljakovine, ovalbumin, formaldehid, kanamicin- in neomicinsulfat (antibiotika) in cetiltrimetilamonijev bromid (CTAB).
Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 274 to 1700 (N=57) and an increase in GMT from 162 to 1399 in children who were seronegative at baseline (N=37).
Podatki o odzivu na drugi odmerek po 3-tedenskem premoru so pokazali zvišanje splošnega GMT s 274 na 1700 (n = 57) in zvišanje GMT od 162 na 1399 pri otrocih, ki so bili ob izhodišču seronegativni (n = 37).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Novartis Vaccines and Diagnostics S.r.l.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Novartis Vaccines and Diagnostics S.r.l.
Intramuscular use.
POSTOPEK UPORABE.
Seronegative at baseline N=45
Seronegativni ob začetku spremljanja n = 45
Seronegative at baseline N=46
Seronegativni ob začetku spremljanja n = 46
Rare (1/10,000 to <1/1,000),
Ugotovljen1 neželeni učinki so navedeni v skladu z naslednjimi pogostnostmi: zelo pogosti (1/10), pogosti (1/100 do <1/10), občasni (1/1000 do <1/100), redki (1/1,000 do <1/1,000), zelo redki (<1/10000).
How to store Focetria
Shranjevanje cepiva FOCETRIA
The other ingredients are: thiomersal (multidose vial only), sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.
Druge sestavine zdravila so: tiomersal (samo v večodmernem vsebniku), natrijev klorid, kalijev klorid, kalijev dihidrogenfosfat, natrijev fosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat, natrijev citrat, citronska kislina in voda za injekcije.
Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 319 to 702 (N=70) and an increase in GMT from 247 to 726 in children who were seronegative at baseline (N=48).
Podatki o odzivu na drugi odmerek po 3-tedenskem premoru so pokazali zvišanje splošnega GMT od 319 na 702 (n = 70) in zvišanje GMT od 247 na 726 pri otrocih, ki so bili ob izhodišču seronegativni (n = 48).
Seronegative at baseline N=25
Seronegativni ob začetku spremljanja n = 25
Focetria suspension for injection Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
Focetria suspenzija za injiciranje cepivo proti gripi H1N1v s površinskimi antigeni, inaktivirano, z adjuvansom
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 and to residues (eggs and chicken protein, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)).
Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (razen anafilaktičnih reakcij) na zdravilno učinkovino, katero koli pomožno snov in ostanke (jajca in kokošje beljakovine, ovalbumin, kanamicin- in neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid (CTAB)).
Prior to administration, the withdrawn vaccine should be allowed to reach room temperature.
Preneseni del cepiva mora pred uporabo doseči sobno temperaturo.
Disorders of the gut such as nausea, vomiting, abdominal pain and diarrhoea.
Bolezni prebavil Bolezni prebavil kot so navzea, bruhanje, bolečina v trebuhu in diareja.
General disorders and administration site conditions Very common: injection site swelling, injection site pain, injection site induration, injection site redness, fatigue, malaise and shivering
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: oteklina na mestu injiciranja, bolečina na mestu injiciranja, zatrdlina na mestu injiciranja, rdečica na mestu injiciranja, slabotnost, utrujenost in tresavica Pogosti: ekhimoza na mestu injiciranja in vročina Občasni: influenci podobna bolezen
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)) of this vaccine.
Anafilatične reakcije v anamnezi (tj. življenjsko nevarne) na katero koli sestavino cepiva ali ostanke v sledeh (jajčne in kokošje beljakovine, ovalbumin, kanamicin- in neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid (CTAB)).
QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/California/07/2009 (H1N1)-derived strain used NYMC X-181 7.5 micrograms** per 0.5 ml dose * propagated in eggs ** expressed in microgram haemagglutinin.
A/California/07/2009 (H1N1) 7,5 mikrogramov** na odmerek 0,5 ml * razmnožen v jajcih ** izraženo v mikrogramih hemaglutinina Adjuvans MF59C.1 vsebuje: skvalen
Fever ≥38°C to 38.9°C Fever 39°C to 39.9°C Fever ≥ 40° C Any other AE
Zvišana telesna temperatura 39 °C/≥39,9 °C Zvišana telesna temperatura ≥40 °C Vsi drugi neželeni učinki
NAME OF THE MEDICINAL PRODUCT Focetria suspension for injection in multidose container Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
Focetria suspenzija za injiciranje v večodmernem vsebniku cepivo proti gripi H1N1v s površinskimi antigeni, inaktivirano, z adjuvansom
Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 307 to 873 (N=66) and an increase in GMT from 243 to 733 in children who were seronegative at baseline (N=45).
Podatki o odzivu na drugi odmerek po 3-tedenskem premoru so pokazali zvišanje splošnega GMT s 307 na 873 (n = 66) in zvišanje GMT od 243 na 733 pri otrocih, ki so bili ob izhodišču seronegativni (n = 45).
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, to thiomersal and to residues (eggs and chicken protein, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)).
Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (razen anafilaktičnih reakcij) na zdravilno učinkovino, katero koli pomožno snov, na tiomersal in ostanke (jajca in kokošje beljakovine, ovalbumin, kanamicin- in neomicinsulfat, formaldehid in cetiltrimetilamonijev bromid (CTAB)) je treba biti previden.
Adverse reactions reported are listed according to the following frequency: Very common (1/10),
Ugotovljeni neželeni učinki so navedeni v skladu z naslednjimi pogostnostmi: zelo pogosti (1/10), pogosti (1/100 do <1/10), občasni (1/1.000 do <1/100), redki (1/10.000 do <1/1.000), zelo redki (<1/10.000).
21 days after 1st dose(day 22)
Starejši (> 60 let) Protitelesa proti HA 21 dni po prvem odmerku (22. dan)
Gastrointestinal disorders Common: nausea
Bolezni prebavil Pogosti: navzea
There are no data with Focetria using the subcutaneous route.
Podatkov o subkutani uporabi cepiva Focetria ni.
Pain, hardening of the skin at the injection site, injection site redness, injection site swelling, pain at the site of injection, aching muscles, headache, sweating, fatigue, generally feeling unwell and shivering
Zelo pogosti (pojavijo se pri več kot 1 cepljeni osebi od 10 cepljenih oseb): bolečina, otrdelost kože na mestu injiciranja, pordečeno in oteklo mesto injiciranja, bolečina na mestu injiciranja, bolečine v mišicah, glavobol, zvečano potenje, utrujenost, splošno slabo počutje in tresavica.
Please consult the Product Information of:
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do:
The seroprotection rate*, seroconversion rate* and the seroconversion factor ** for anti-HA antibody to A/H1N1v in adult and elderly subjects by HI assay after administration of 7.5 µg of Focetria were as follows:
Stopnja serološke zaščite*, stopnja serološke konverzije* in faktor serološke konverzije**, izmerjeni s testom HI za HA protitelesa proti A/H1N1v po dajanju 7,5 µg cepiva Focetria, so bili pri odraslih naslednji:
MARKETING AUTHORISATION HOLDER Novartis Vaccines and Diagnostics S.r.l.
IMETNIK DOVOLJENJA ZA PROMET Novartis Vaccines and Diagnostics S.r.l.
NAME OF THE MEDICINAL PRODUCT Focetria suspension for injection in pre-filled syringe Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
Focetria suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti gripi H1N1v s površinskimi antigeni, inaktivirano, z adjuvansom
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in children aged 12-35 months by HI assay after administration of 7.5 µg of Focetria were as follows:
Stopnja serološke zaščite*, stopnja serološke konverzije* in faktor serološke konverzije** izmerjeni s testom HI za HA protitelesa H1N1v, po dajanju 7,5 µg cepiva Focetria pri otrocih, starih od 12-35 mesecev, so bili naslednji:
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in infants aged 6-11 months by HI assay after administration of 7.5 µg of Focetria were as follows:
Stopnja serološke zaščite*, stopnja serološke konverzije* in faktor serološke konverzije** izmerjeni s testom HI za HA protitelesa H1N1v, po dajanju 7,5 µg cepiva Focetria pri dojenčkih, starih od 6-11 mesecev, so bili naslednji:
A dose (0.5 ml) of the vaccine will be given.
Prejmejo odmerek (0,5 ml).
A/California/07/2009 (H1N1)-derived strain used NYMC X-181 7.5 micrograms haemagglutinin
A/California/07/2009 (H1N1)
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in children aged 3-8 years by HI assay after administration of 7.5 µg of Focetria were as follows:
Stopnja serološke zaščite*, stopnja serološke konverzije* in faktor serološke konverzije** po dajanju 7,5 µg cepiva Focetria, izmerjeni s SRH za protitelesa proti HA seva H1N1v, so bili pri otrocih, starih od 3 do 8 let, naslednji:
Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, thiomersal, water for injections.
SEZNAM POMOŽNIH SNOVI natrijev klorid, kalijev klorid, kalijev dihidrogenfosfat, natrijev fosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat, natrijev citrat, citronska kislina, tiomersal, voda za injekcije.
Sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid, water for injections.
SEZNAM POMOŽNIH SNOVI natrijev klorid, kalijev klorid, kalijev dihidrogenfosfat, natrijev fosfat dihidrat, magnezijev klorid heksahidrat, kalcijev klorid dihidrat, natrijev citrat, citronska kislina, voda za injekcije.
Talk to your doctor or nurse before receiving Focetria
Preden prejmete cepivo Focetria, se posvetujte s svojim zdravnikom ali z medicinsko sestro.
Respiratory disorders Cough.
Bolezni dihal Kašelj.
Children and Adolescents (9-17 years)
Otroci in mladostniki (9-17 let) Protitelesa proti HA 21 dni po prvem odmerku (22. dan)
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in children and adolescents aged 9-17 years by HI assay administration of 7.5 µg of Focetria were as follows:
Stopnja serološke zaščite*, stopnja serološke konverzije* in faktor serološke konverzije** izmerjeni s testom HI za HA protitelesa H1N1v, po dajanju 7,5 µg cepiva Focetria pri otrocih in mladostnikih, starih od 9-17 let:
Ready-to-use syringe, containing a single dose of 0.5 ml for injection:
Za uporabo pripravljena napolnjena injekcijska brizga z enkratnim odmerkom 0,5 ml za injiciranje: Cepivo mora pred uporabo doseči sobno temperaturo.