natgillin/translations-raw huggingface dataset:
After 3 weeks from the 2nd vaccination (day 43) all age groups (i.e. 6-35 months, 3-8 years and 9-17 years) achieved high levels of antibodies to (A/Vietnam/1194/2004) as evaluated with SRH and HI assays as presented in table below*.
Po 3 tednih od 2. cepljenja (43. dan) so vse starostne skupine (tj. 6-35 mesecev, 3-8 let in 9-17 let) dosegle visoko raven protiteles na sev (A/Vietnam/1194/2004), ocenjeno s testoma SRH in HI, kot je predstavljeno v spodnji preglednici*.
The European Medicines Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Evropska agencija za zdravila (EMA) bo vsako leto ponovno pregledala vse nove podatke o tem zdravilu.
Some cases were observed in subjects with a history of epilepsy.
Nekaj primerov so ugotovili pri osebah z epilepsijo v anamnezi.
Data obtained with a pandemic preparedness vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical efficacy and safety data obtained with pandemic preparedness vaccines are relevant for the pandemic vaccines.
Podatki, pridobljeni z uporabo cepiva za pripravljenost na pandemijo, bodo podprli strategijo cepljenja, ki se bo verjetno uporabila za cepivo proti pandemični gripi: podatki o klinični učinkovitosti in varnosti, pridobljeni s cepivi za pripravljenost na pandemijo, veljajo za cepiva proti pandemični gripi.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Po cepljenju ali celo pred cepljenjem se lahko pojavi sinkopa (omedlevica) kot psihogeni odziv na injekcijsko iglo.
Packs of 1 and 10 with or without needle.
Pakiranja po 1 in 10 injekcijskih brizg z iglo ali brez nje.
Foclivia should not be given at the same time as other vaccines.
Zdravila Foclivia se ne sme dajati sočasno z drugimi cepivi.
- Periodicity should be reviewed by the MAH and the (Co-)Rapporteur at 6 monthly intervals.
- Imetnik dovoljenja za promet z zdravilom in (so-)poročevalec bosta ocenila periodičnost v šestmesečnih presledkih.
The doctor should inform you about the posibility to experience convulsion, in particular if you have had previous history of epilepsy.
Zdravnik vas bo obvestil o možnosti pojava epileptičnih krčev, zlasti če ste ga v preteklosti že imeli.
Important information about some of the ingredients of Foclivia Foclivia contains thiomersal
Pomembne informacije o nekaterih sestavinah zdravila Foclivia Zdravilo Foclivia vsebuje tiomersal
Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
Po cepljenju proti gripi se lahko pojavijo lažno pozitivni serološki testi z metodo ELISA za določanje protiteles proti humanemu virusu imunske pomanjkljivosti (HIV-1), virusu hepatitisa C in zlasti virusu HTLV-1.
Cross reactivity
Navzkrižne reakcije
Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
Obvestite zdravnika ali medicinsko sestro, če imate težave s strjevanjem krvi ali če ste nagnjeni k podplutbam.
These antigens can be considered as ‘novel' antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Ti antigeni delujejo kot „novi“ antigeni in posnemajo stanje, pri katerem ciljna populacija še ni bila cepljena.
Prophylaxis of influenza in an officially declared pandemic situation.
Profilaksa influence pri uradno razglašeni pandemiji.
Like all medicines, Foclivia can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Foclivia neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
H5N1 adjuvanted vaccine
Cepivo H5N1 z adjuvansom
Syringes without needle are fitted with a Luer Lock system.
Injekcijske brizge brez igle so opremljene s sistemom luer-lock.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALEC (IZDELOVALCI),
Immunisation should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Imunizacijo je treba opraviti z intramuskularnim injiciranjem v deltoidno mišico ali anterolateralni predel stegna (odvisno od mišične mase).
What you need to know before you receive Foclivia Foclivia should not be given if you:
Kaj morate vedeti, preden boste prejeli zdravilo Foclivia Zdravila Foclivia ne smete prejeti, če:
Foclivia is a vaccine intended to be given to prevent influenza (flu) in an officially declared pandemic.
Zdravilo Foclivia je cepivo, ki je namenjeno dajanju za preprečevanje gripe v uradno razglašenih pandemičnih razmerah.
Postmarketing spontaneously reported adverse events and an interventional study do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy.
Neželeni učinki, zabeleženi v obdobju trženja zdravila in v intervencijski študiji, ne nakazujejo neposrednih ali posrednih škodljivih učinkov izpostavite zdravilu Focetria na nosečnost.
In addition, two large observational studies designed to assess the safety of Focetria exposure in pregnancy showed no increase in the rates of gestational diabetes, preeclampsia, abortions, stillbirth, low birth weight, prematurity, neonatal deaths, and congenital malformations among almost 10.000 vaccinated pregnant women and their offspring compared with unvaccinated controls.
Poleg tega sta bili izvedeni dve veliki opazovalni študiji za oceno varnosti izpostavitve zdravilu Focetria v nosečnosti, v katerih pri skoraj 10.000 cepljenih nosečnicah in njihovih otrocih v primerjavi z necepljenimi kontrolnimi osebami niso dokazali povečanih stopenj gestacijske sladkorne bolezni, preeklampsije, splavov,
Very common reactions reported in 146 infants and toddlers 6 to 35 months of age: Tenderness, erythema, irritability, unusual crying, sleepiness, diarrhoea, vomiting and change in eating habits.
Zelo pogosti neželeni učinki, ugotovljeni pri 146 dojenčkih in malčkih, starih od 6 do 35 mesecev: občutljivost na dotik, eritem, razdražljivost, neobičajno jokanje, zaspanost, driska, bruhanje in sprememba prehranjevalnih navad.
* measured by SRH assay ≥ 25 mm2 ** geometric mean ratios of SRH
* izmerjeno s testom SRH ≥ 25 mm2 ** razmerja geometričnih povprečij za SRH
Do not use Foclivia after the expiry date which is stated on the carton and the label after EXP.
Zdravila Foclivia ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in ovojnini poleg oznake „Uporabno do/Upor.
Record date and time of the first dose withdrawal on the vial label.
Na nalepko viale zabeležite datum in uro prvega odvzema odmerka.
Foclivia should under no circumstances be administered intravascularly or subcutaneously.
Zdravilo Foclivia se v nobenem primeru ne sme dajati intravaskularno ali subkutano.
Frequency of Adverse reactions in clinical trials and postmarketing surveillance is reported hereunder.
V nadaljevanju je prikazana pogostnost neželenih učinkov v kliničnih preskušanjih in pri nadzoru v obdobju trženja zdravila.
It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional, nonadjuvanted influenza vaccines.
Splošno sprejeto je, da učinek adjuvansa privede do večje imunogenosti, ki je povezana z rahlo večjo pogostnostjo lokalnih reakcij (večinoma blaga bolečina) kot pri običajnih cepivih proti gripi brez adjuvansa.
Across all ages, low percentages of subjects reported fever.
V vseh starostnih skupinah je majhen delež oseb navedel zvišano telesno temperaturo.
In some cases the effects may also include raised temperature, malaise (generally feeling unwell), shivering, tiredness, headache, sweating, pain in muscles and joints.
V nekaterih primerih so učinki lahko tudi zvišana telesna temperatura, slabotnost (splošno slabo počutje), tresenje, utrujenost, glavobol, potenje, bolečine v mišicah in sklepih.
Immunogenicity results with Focetria H1N1v (Study V111_03):
Rezultati imunogenosti z zdravilom Focetria H1N1v (študija V111_03):
Children (3-<9 years)
Otroci (3-<9 let)
Any adverse reaction Local
Vsi neželeni učinki Lokalni
0.04 milligrams
0,04 miligramov
Cardiac disorders Palpitation, tachycardia.
Srčne bolezni palpitacije, tahikardija
The vaccine should not be administered intravascularly or subcutaneously.
Cepivo se ne sme dajati intravaskularno ali subkutano.
Elderly (>60 years)
Starejši (> 60 let)
It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional,
Splošno sprejeto je, da učinek adjuvansa privede do večje imunogenosti, ki je povezana z rahlo večjo pogostnostjo lokalnih reakcij (večinoma blaga bolečina)
In some cases the effects may also include raised temperature, malaise (generally feeling unwell), shivering,
V nekaterih primerih so učinki lahko tudi zvišana telesna temperatura, slabotnost (splošno slabo počutje),
From the clinical trials conducted with the pandemic preparedness adjuvanted H5N1 vaccine in adult and elderly (see section 5.1 for more information), most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
V kliničnih preskušanjih, opravljenih s cepivom proti gripi H5N1 za pripravljenost na pandemijo z dodanim adjuvansom pri odraslih in starejših (za več informacij glejte poglavje 5.1), je bilo največ neželenih učinkov blage narave s kratkih trajanjem in kvalitativno podobnih neželenim učinkom običajnih cepiv proti sezonski gripi.
Persistence of antibodies after primary vaccination in this population was assessed by Hemagglutination Inhibition (HI), SRH, and MN assays.
Obstojnost protiteles po primarnem cepljenju v tej populaciji je bila ocenjena s testi zaviranja hemaglutinacije (HI - hemagglutination inhibition), SRH in MN.
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, pridobljeni pri otrocih in mladostnikih, starih 3-17 let, nakazujejo manjši upad reaktogenosti po drugem odmerku brez povečanja pogostnosti stopenj zvišane telesne temperature.
Second dose (21 days after first dose)
Drugi odmerek (21 dni po prvem odmerku)
5 ml vial containing 10 doses (0.5 ml/dose)
5-mililitrska viala, ki vsebuje 10 odmerkov (0,5 ml/odmerek)
The European Medicines Agency (EMA) will review any new information which may become available every year and this SmPC will be updated as necessary.
Evropska agencija za zdravila (EMA) bo vsako leto pregledala vse nove podatke, ki bodo na voljo.
Blood and lymphatic system disorders Lymphadenopathy.
Bolezni krvi in limfatičnega sistema limfadenopatija
Numbness or tingling sensations, involuntary muscle contractions or thrombocytopenia (reduction in the number of certain types of particles in the blood called plateles; a low number of these can result in excessive bruising or bleeding).
Občutek otrplosti ali mravljinčenja, nenadzorovano krčenje mišic ali trombocitopenija (zmanjšano število krvnih celic, imenovanih krvne ploščice; nizko število lahko povzroči čezmerne modrice ali krvavitve).
Toddlers (6-<36 months)
Malčki (6-<36 mesecev)
Infants (6 to 11 months of age)
Dojenčki (stari od 6 do 11 mesecev)
Regardless of age, reactogenicity was higher after the first dose than after the second vaccination.
Po prvem odmerku je bila reaktogenost večja kot po drugem odmerku ne glede na starost.
Once the needle is locked in place, remove the needle protector and administer the vaccine.
Ko se igla zaskoči, odstranite ščitnik igle in aplicirajte cepivo.
The European medicines Agency has deferred the obligation to submit the results of studies with Foclivia in one or more subsets of the paediatric populations in active immunisation against H5N1 subtype of Influenza A virus.
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Foclivia za eno ali več podskupin pediatrične populacije za aktivno imunizacijo proti podtipu H5N1 virusa influence A. Za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.
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, pridobljeni pri dojenčkih in malčkih, starih 6-35 mesecev, nakazujejo manjši upad reaktogenosti po drugem odmerku brez povečanja pogostnosti stopenj zvišane telesne temperature.
Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.
Bolezni imunskega sistema alergijske reakcije, anafilaksa, vključno z dispnejo, bronhospazem, laringialni edem, ki v redkih primerih vodijo v šok
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, ugotovljene pri otrocih in mladostnikih, starih od 3 do 17 let: bolečina, induracija in eritem, splošno slabo počutje, mialgija, glavobol in utrujenost.
Third dose (12 months after second dose)
Tretji odmerek (12 mesecev po drugem odmerku)
Serologic responses obtained with the SRH assay showed that 100% of subjects achieved seroprotection and 100% seroconverted after two 7.5 µg injections.
Serološki odziv, pridobljen z metodo SRH, je pokazal, da je do serološke zaščite prišlo pri 100 % oseb in da se je po dveh 7,5-mikrogramskih injekcijah pri 100 % pojavila serološka konverzija.
The active ingredients of the vaccine are purified viral proteins (called haemagglutinin and neuraminidase).
Učinkovini cepiva sta prečiščeni virusni beljakovini (imenovani hemaglutinin in nevraminidaza).
When using a pre-filled syringe without a needle supplied with a Luer Lock system, remove the tip cap by unscrewing it in a counter-clockwise direction.
Če uporabljate napolnjeno injekcijsko brizgo brez igle, opremljeno s sistemom luer-lock, odstranite pokrovček konice, tako da jo odvijete v nasprotni smeri ure.
In children and adolescents pain was the most frequently reported solicited local reaction, and fatigue and headache were the most commonly reported solicited systemic reactions.
Pri otrocih in mladostnikih je bila bolečina in najpogostejša izzvana lokalna reakcija, utrujenost in glavobol pa najpogostejši izzvani sistemski reakciji.
Breast-feeding The vaccine may be used during lactation.
Dojenje Cepivo se lahko uporablja med dojenjem.
** geometric mean ratios of SRH ° measured by HI assay ≥ 40 °° geometric mean ratios of HI *** In V87P1: baseline not tested
* izmerjeno s testom SRH ≥ 25 mm2 ** razmerja geometričnih povprečij za SRH ° izmerjeno s testom ≥ 40 °° razmerja geometričnih srednjih vrednosti za HI *** v V87P1: izhodišče ni bilo testirano
Safety data after the first and second dose in children and adolescents with a similar pandemic vaccine (Focetria H1N1v) suggest a comparable safety profile with that reported for the aH5N1 pandemic preparedness vaccine formulation (Foclivia).
Varnostni podatki po prvem in drugem odmerku pri otrocih in mladostnikih s podobnim cepivom (Focetria H1N1v) kažejo varnostni profil, ki je primerljiv z varnostnim profilom cepiva proti aH5N1 za pripravljenost na pandemijo (Foclivia).
The vaccine may be used during lactation.
Cepivo se lahko uporabi v obdobju dojenja.
Induration and ecchymosis were very common reactions in toddlers but were less common in infants.
Induracija in ekhimoza sta bila zelo pogosta neželena učinka pri malčkih, vendar manj pogosta pri dojenčkih.
Adverse event(s) from post-marketing surveillance with the pandemic vaccine: not applicable.
Neželeni učinek (učinki) iz postmarketinškega nadzora cepiva proti pandemični gripi: navedba smiselno ni potrebna.
Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Zdravnik mora presoditi koristi in možno tveganje uporabe cepiva pri osebah s trombocitopenijo ali katero koli motnjo koagulacije, pri kateri je intramuskularno injiciranje kontraindicirano, razen če pričakovane koristi odtehtajo tveganje krvavitve.
Fainting can occur following, or even before, any needle injection.
Po injiciranju ali celo pred njim se lahko pojavi omedlevica.
Seroprotection rate (95% CI) Day 43 Seroconversion factor (95% CI) Day 43 to Day 1 Seroconversion rate (95% CI) Day 43
43. dan Faktor serokonverzije (95-odstotni IZ) 43. dan do 1. dan Stopnja serokonverzije (95-odstotni IZ) 43. dan
Pregnancy No data have been generated with Foclivia in pregnant women.
Podatkov o uporabi zdravila Foclivia pri nosečnicah ni.
General disorders and administration site conditions Common (>1/100, <1/10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering The majority of these reactions usually disappear within 1-2 days without treatment.
Splošne težave in spremembe na mestu aplikacije Pogosti (>1/100, <1/10): rdečica na mestu injiciranja, otekanje na mestu injiciranja, induracija na mestu injiciranja, ekhimoza na mestu injiciranja in bolečina na mestu injiciranja, zvišana telesna temperatura, slabotnost, utrujenost in tresenje Večina teh reakcij navadno izgine v 1 do 2 dneh brez zdravljenja.
In toddlers, erythema and tenderness were the most commonly reported solicited local reactions; irritability and unusual crying were the most commonly reported solicited systemic reactions.
Pri malčkih sta bila eritem in občutljivost na dotik najpogostejši izzvani lokalni reakciji, razdražljivost in neobičajno jokanje pa najpogostejši izzvani sistemski reakciji.
0.05 milligrams
0,05 miligramov
A third (booster) dose of H5N1 vaccine combined with MF59C was administered 6 months onwards after the primary vaccination series.
Obnovitveni odmerek Tretji (obnovitveni) odmerek cepiva proti H5N1 z dodanim MF59C je bil dan po 6 ali več mesecih po primarnem cepljenju.
There were fewer reactions after the second dose compared with the first.
Po drugem odmerku je bilo manj neželenih učinkov kot po prvem odmerku.
Children (3 to 8 years of age)
Otroci (stari od 3 do 8 let)
The incidence of adverse reactions was evaluated in four clinical trials with different influenza strains and formulations (H5N3, H9N2 and H5N1); 3696 adults and elderly subjects were exposed.
Neželeni učinki iz kliničnih preskušanj pri odraslih in starejših osebah (starih 18 let ali več) Pojavnost neželenih učinkov so ocenili v štirih kliničnih preskušanjih z različnimi sevi in formulacijami virusa gripe (H5N3, H9N2 in H5N1); cepivu je bilo izpostavljenih 3.696 odraslih in starejših oseb.
Adverse Events of Special Interest stratified according to type of report (medically confirmed or non-medically confirmed).
Neželeni učinki posebnega interesa, stratificirani glede na vrsto poročila (medicinsko potrjeni ali nemedicinsko potrjeni).
Content of the pack and other information What Foclivia contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Foclivia
Visually inspect the suspension prior to administration.
Suspenzijo pred uporabo preglejte s prostim očesom.
“Possible side effects” may affect your ability to drive or use tools or machines.
„Neželeni učinki“, lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Če bolnik prejema imunosupresijsko zdravljenje, se lahko zmanjša imunološki odziv.
10 x 10 doses 1 dose (0.5 ml)
10 x 1 odmerek 1 odmerek (0,5 ml)
1 x single dose (0.5 ml) pre-filled syringe with needle 1 x single dose (0.5 ml) pre-filled syringe without needle 10 x single dose (0.5 ml) pre-filled syringes with needle 10 x single dose (0.5 ml) pre-filled syringe without needle
1 napolnjena injekcijska brizga z iglo z enkratnim odmerkom (0,5 ml) 1 napolnjena injekcijska brizga brez igle z enkratnim odmerkom (0,5 ml) 10 napolnjenih injekcijskih brizg z iglo z enkratnim odmerkom (0,5 ml) 10 napolnjenih injekcijskih brizg brez igle z enkratnim odmerkom (0,5 ml)
Data on a third dose (booster) administered 6 months after the first dose are limited (see sections 4.8 and 5.1).
Podatki o tretjem odmerku (obnovitvenem) 6 mesecev po prvem odmerku so omejeni (glejte poglavji 4.8 in 5.1).
What Foclivia looks like and contents of the pack
Izgled zdravila Foclivia in vsebina pakiranja
Anti-HA antibody
Protitelo proti HA
Redness, swelling, pain at the site of injection, bruising, hardening of the skin injection site.
Rdečica, otekanje, bolečina na mestu injiciranja, modrice, otrditev kože na mestu injiciranja.
Of these subjects, 3618 subjects received the pandemic preparedness vaccine Foclivia (A/H5N1) (see section 5.1).
Med njimi je 3.618 oseb prejelo cepivo Foclivia za pripravljenost na pandemijo (A/H5N1) (glejte poglavje 5.1).
Foclivia contains sodium and potassium
Zdravilo Foclivia vsebuje natrij in kalij
Once the tip cap is removed, attach a needle to the syringe by screwing it on in a clockwise direction until it locks.
Ko odstranite pokrovček konice, na injekcijsko brizgo pritrdite iglo, tako da jo privijate v smeri ure, dokler se ne zaskoči.
Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Nevrološke bolezni, kot so nevralgija, parestezija, konvulzije in nevritis
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Vietnam/1194/2004 (H5N1)
Površinski antigeni (hemaglutinin in nevraminidaza)* naslednjega seva virusa influence: A/Vietnam/1194/2004 (H5N1)
narrow SMQ “Anaphylactic reaction” and narrow SMQ “Angioedema”
zoženo SMQ „Anafilaktična reakcija“ in zoženo SMQ
In another clinical trial (Phase III) (Study V87P13), 2693 healthy adults were enrolled and received two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/dose adjuvanted) administered three weeks apart.
V drugo klinično preskušanje (3. faza) (študija V87P13) so vključili 2.693 zdravih odraslih prostovoljcev, ki je v 3-tedenskem presledku prejelo dva odmerka cepiva, ki vsebuje H5N1 (A/Vietnam/1194/2004; 7,5 µg HA/odmerek z adjuvansom).
Foclivia was evaluated in adults (18 to 60 years old) and elderly (over 60 years old) following a 1, 22 day primary vaccination schedule.
Zdravilo Foclivia je bilo ocenjeno pri odraslih (starih od 18 do 60 let) in starejših bolnikih (starih več kot 60 let) po razporedu primarnega cepljenja 1, 22. dan.
per 0.5 ml dose
na odmerek 0,5 ml
How to store Foclivia
Kako uporabljati zdravilo Foclivia
Between uses, return the multidose vial to the recommended storage conditions between 2° and 8° C. The multidose vial should preferably be used within 24 hours after first withdrawal.
Večodmerno vialo med uporabami vrnite v priporočene pogoje shranjevanja med 2 °C in 8 °C.
- Rapporteur's assessment report is circulated to CHMP members on Day 50.
- Poročilo z oceno poročevalca se članom CHMP predloži 50. dan. - Poročilo CHMP se izdelovalcu cepiva predloži 55. dan. - Poročanje je prvih 6 mesecev mesečno.
Muscoskeletal, connective tissue and bone disorders Common (>1/100, <1/10): arthralgia and myalgia
Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti (>1/100, <1/10): artralgija in mialgija
Muscoskeletal and connective tissue and bone disorders Muscular weakness, pain in extremities.
Bolezni mišično-skeletnega sistema in vezivnega tkiva mišična šibkost, bolečine v okončinah
Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event Adolescents(9-<18 years)
Zvišana telesna temperatura ≥ 40 °C Vsi drugi neželeni učinki Mladostniki (stari od 9 do 17 let)
In addition to the adverse reactions reported in the clinical trials, the following have been reported during post-marketing experience with Focetria H1N1v:
Poleg neželenih učinkov, ugotovljenih v kliničnih preskušanjih, so bili za zdravilo Focetria H1N1v ugotovljeni naslednji neželeni učinki med nadzorom v obdobju trženja: