natgillin/translations-raw huggingface dataset:
Therefore, the relevant SmPC wording currently stating the limited availability of clinical data in pregnant women, is recommended to be changed to reflect the newly available information.
Zato se priporoča sprememba besedila SmPC, ki opisuje omejeno razpoložljivost kliničnih podatkov o nosečnicah, da bo odražalo nove podatke.
Additional information is available from the studies conducted with a vaccine similar in composition to Focetria but containing antigen derived from H5N1 viruses.
Dodatne informacije so na voljo iz študij, izvedenih s cepivom podobne sestave, kot je sestava cepiva focetria, a z antigenom, pridobljenim iz virusov H5N1.
• The MAH shall agree with Member States on the provision of a targeted communication to healthcare professionals which should address the following:
• Imetnik dovoljenja za promet z zdravilom se bo dogovoril z državami članicami o zagotavljanju ciljanega obveščanja za zdravnike, ki mora obravnavati naslednje:
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the marketing authorisation, is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 dovoljenja za promet vzpostavljen in deluje, preden začne tržiti cepivo in ves čas trženja cepiva.
Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).
Cepljenje je treba opraviti z intramuskularnim injiciranjem po možnosti v deltoidno mišico ali v anterolateralni predel stegna (odvisno od mišične mase).
Between uses, return the multidose vial to the recommended storage conditions between 2° and 8° C (36° and 46° F).
Med uporabami shranjujte večodmerno vialo pod priporočenimi pogoji shranjevanja med 2 °C in 8 °C.
Like all medicines, Focetria can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi cepivo Focetria neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Record date and time of the first dose withdrawal on the vial label.
Datum in čas odvzema prvega odmerka zabeležite na nalepki viale.
1.175 milligrams
1,175 miligramov
Rare: Low blood platelet count which can result in bleeding or bruising.
Redki: Zmanjšano število trombocitov v krvi, kar lahko povzroči krvavitve ali modrice.
GMR (95% CI)
GMR (95-% IZ)
1.175 milligrams sorbitan trioleate
1,175 miligramov sorbitantrioleat
Elderly (>60 years):
Starostniki (>60 let):
Paediatric population Children and adolescents 6 months to 17 years of age
Pediatrična populacija Otroci in mladostniki, stari od 6 mesecev do 17 let
Postmarketing spontaneously reported adverse events, an interventional study and large observational studies do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy.
Neželeni učinki, o katerih so spontano poročali v obdobju trženja zdravila, intervencijska študija in velike opazovalne študije ne kažejo na neposredne ali posredne škodljive učinke izpostavljenosti cepiva Focetria na nosečnost.
A second dose of vaccine should be given after an interval of at least three weeks.
Drugi odmerek cepiva se uporabi po presledku vsaj 3 tednov.
Tell the doctor requesting these tests that you have recently been given Focetria.
Obvestite zdravnika, ki vas je napotil na takšne preiskave, da ste se pred nedavnim cepili s cepivom Focetria.
Rare: Transient thrombocytopenia.
Redki: Prehodna trombocitopenija.
What Focetria is and what it is used for What you need to know before you receive Focetria How Focetria is given
Kaj je cepivo Focetria in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli cepivo Focetria Kako boste prejeli cepivo Focetria Možni neželeni učinki
Adverse reactions from clinical trials with the mock-up vaccine are listed below.
Neželeni učinki v kliničnih preskušanjih z modelnim cepivom so navedeni spodaj.
Adults (18-60 years):
Odrasli (18-60 let):
What Focetria looks like and contents of the pack Focetria is a milky-white liquid.
Videz cepiva Focetria in vsebina pakiranja Cepivo Focetria je mlečno bela tekočina.
The safety profile of Focetria was similar to that of the H5N1 mock up vaccines.
Varnostni profil cepiva Focetria je bil podoben varnostnemu profilu modelnih H5N1 cepiv.
The side-effects are generally similar to those related to the seasonal flu vaccine.
Neželeni učinki so bili na splošno podobni kot pri cepivu proti sezonski gripi.
The incidence of symptoms observed in subjects over 60 years of age was generally lower as compared to the 18-60 years old population.
Pogostnost simptomov, ki so jih opazili pri osebah, starih več kot 60 let, je bila na splošno manjša kot pri populaciji oseb, starih od 18 do 60 let.
SCIENTIFIC CONCLUSIONS AND GROUNDS RECOMMENDING THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA ZA PROMET Z ZDRAVILOM
MF59C.1 is an oil/water emulsion containing 9.75 mg squalene, 1.175 mg polysorbate 80 and 1.175 mg sorbitan trioleate in a citrate buffer.
MF59C.1 je emulzija iz olja in vode, ki vsebuje 9,75 mg skvalena, 1,175 mg polisorbata 80 in 1,175 mg sorbitantrioleata v citratnem pufru.
7.5 micrograms** per 0.5 ml dose
7,5 mikrogramov** na odmerek 0,5 ml
Do not receive Focetria:
Cepiva Focetria ne smete prejeti:
It is recommended that subjects who receive a first dose of Focetria, should complete the vaccination course with Focetria H1N1v (see section 4.4).
Priporočljivo je, da osebe, ki so prejele prvi odmerek cepiva Focetria, cepljenje tudi zaključijo s cepivom Focetria H1N1v (glejte poglavje 4.4).
10 x 10 doses of 0.5 ml vaccine (5 ml)
10 x 10 odmerkov cepiva z 0,5 ml (5 ml)
Allergic reactions possibly with shortness of breath, wheezing, swelling of the throat, or leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock.
Alergijske reakcije, ki so lahko vključevale kratko sapo, sopenje, oteklost grla ali alergijske reakcije, ki povzročijo nevarno znižanje krvnega tlaka, ki lahko, če stanje ni zdravljeno, povzročijo šok.
Available clinical data suggest that a single dose may be sufficient.
Klinični podatki, ki so na voljo kažejo, da lahko zadošča en sam odmerek.
Particular attention should be given to subjects suffering from epilepsy and the physician should inform the subjects (or parents) about the possibility to experience convulsion.
Posebno pozornost je treba posvetiti osebam, ki imajo epilepsijo, zdravnik pa mora osebe (ali starše) obvestiti o možnosti nastanka konvulzij (glejte poglavje 4.8).
Prophylaxis of influenza caused by A (H1N1v) 2009 virus (see section 4.4).
Preprečevanje gripe, ki jo povzroča virus A(H1N1v) 2009 (glejte poglavje 4.4).
Some cases were observed in subjects with a history of epilepsy.
Nekatere primere so opazili pri osebah z epilepsijo v anamnezi.
Clinical data suggest that a single dose may be sufficient.
Klinični podatki kažejo, da lahko zadošča en sam odmerek.
Quantities are expressed per 0.5 ml vaccine dose.
Količine so izražene na 0,5 ml odmerek cepiva.
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, o katerih so poročali v kliničnih preskušanjih, so iz izkušenj v obdobju trženja zdravila poročali o naslednjih neželenih učinkih s cepivom Focetria H1N1v:
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 so poročali o lažno pozitivnih rezultatih seroloških testov z metodo ELISA za odkrivanje protiteles proti virusu humane imunske pomanjkljivosti 1 (HIV-1), virusu hepatitisa C in zlasti proti virusu HTLV-1.
The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)v-like strains.
Pričakuje se, da cepivo ščiti le pred gripo, ki jo povzročijo sevi, podobni A/California/07/2009 (H1N1)v.
Any adverse reaction Local
Kateri koli neželeni učinek Lokalni
- The active substance is:
- Zdravilna učinkovina je:
The incidence of symptoms observed in subjects over 60 years of age was lower as compared to the 18-60 years old population.
Pogostnost simptomov, ki so jih opazili pri osebah, starih več kot 60 let, je bila manjša kot pri populaciji oseb, starih od 18 do 60 let.
Non-clinical data obtained with the mock-up vaccine (MF59C.1-adjuvanted H5N1 vaccine) and with seasonal vaccine containing MF59C.1 adjuvant reveal no special hazard for humans based on conventional studies of efficacy, repeated dose toxicity, and reproductive and developmental toxicity.
Neklinični podatki, pridobljeni z modelnim cepivom (cepivo H5N1 z adjuvansom MF59C.1) in sezonskim cepivom, ki je vsebovalo adjuvans MF59C.1, na osnovi običajnih študij učinkovitosti, toksičnosti pri ponavljajočih se odmerkih, vpliva na sposobnost razmnoževanja in razvoj ne kažejo posebnih tveganj za človeka.
Further, data from vaccinations with seasonal interpandemic inactivated trivalent vaccines in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine.
Tudi podatki o cepljenjih nosečnic s sezonskimi interpandemičnimi trivalentnimi cepivi ne kažejo, da bi bili neželeni izidi pri plodu in materi lahko posledice cepiva.
Do not use Focetria after the expiry date which is stated on the carton and the label.
Cepiva Focetria ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in ovojnini.
Adjuvant: MF59C.1 oil in water emulsion containing squalene, as the oil phase, stabilised with polysorbate 80 and sorbitan trioleate in a citrate buffer.
Adjuvans: MF59C.1 emulzija olja v vodi, ki vsebuje skvalen kot oljno fazo, stabilizirana s polisorbatom 80 in sorbitantrioleatom v citratnem pufru.
Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems), exudative erythema multiforme.
Vaskulitis (vnetje krvnih žil, ki lahko povzroči kožne izpuščaje, bolečine v sklepih in težave z ledvicami), eksudativni multiformni eritem.
In clinical trial 131 adults and 123 elderly were exposed to two doses of the 7.5 µg Focetria.
V kliničnem preskušanju se je cepilo 131 odraslih in 123 starejših oseb z dvema odmerkoma 7,5 µg cepiva Focetria.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Znaki alergijske reakcije so lahko srbeč kožni izpuščaj, zasoplost in otekanje obraza ali jezika.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Multidose vial (5 ml)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT Viala (5 ml) z več odmerki
Rare: anaphylaxis
Redki: anafilaksa
Induration was a common reaction in toddlers but was less common in infants.
Zatrdlina je bila pri malčkih pogost neželen učinek, pri dojenčkih pa manj pogost.
Neurological disorders, such as encephalomyelitis and Guillain Barré syndrome.
Nevrološke motnje, kot so encefalomielitis in Guillain-Barréjev sindrom.
Immunogencity results with two doses of 7.5 µg Focetria H1N1v vaccine from the ongoing clinical trial in adults and elderly are shown below.
Rezultati imunogenosti z dvema odmerkoma 7,5 µg cepiva H1N1v Focetria iz kliničnega preskušanja, ki je v teku pri odraslih in starostnikih so prikazani spodaj.
If they persist, CONSULT YOUR DOCTOR.
Če ne izginejo, SE POSVETUJTE Z ZDRAVNIKOM.
Neurological disorders such as severe stabbing or throbbing pain along one or more nerves, tingling, fits, and neuritis (inflammation of nerves).
Nevrološke motnje kot so zbadanje ali prebijajoča bolečina vzdolž enega ali več živcev, mravljinčenje, krči in nevritis (vnetje živcev).
Vasculitis with transient renal involvement and exudative erythema multiforme.
Vaskulitis s prehodno prizadetostjo ledvic in eksudativni multiformni eritem.
Via Fiorentina, 1 - Siena, Italy.
Via Fiorentina, 1 - Siena, Italija
Grounds recommending the variation to the terms of the Marketing Authorisation On the basis of the scientific conclusions for Focetria, the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing the active substance influenza vaccine h1n1v (surface antigen, inactivated, adjuvanted) is favourable subject to the proposed changes to the product information.
Podlaga za priporočilo spremembe pogojev dovoljenja za promet z zdravilom Na podlagi znanstvenih zaključkov za cepivo Focetria odbor CHMP meni, da je razmerje med koristmi in tveganji zdravila, ki vsebujejo zdravilno učinkovino cepivo proti gripi H1N1v (s površinskimi antigeni, inaktivirano, z adjuvansom), ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
The vaccine should be allowed to reach room temperature before use.
Cepivo mora pred uporabo doseči sobno temperaturo.
Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.
Alergijske reakcije, anafiksa vključno z dispnejo, bronhospazmom, edemom grla, ki so v redkih primerih povzročili šok.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/385/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/385/001
Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
Večina neželenih učinkov je bila blagih in kratkotrajnih in po lastnostih podobnih neželenim učinkom, ki jih povzročajo običajna cepiva proti sezonski gripi.
METHOD AND ROUTE(S) OF ADMINISTRATION To be administered intramuscularly into the deltoid muscle.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Injicirajte intramuskularno v deltoidno mišico.
Nervous system disorders Very common: headache Rare: convulsions
Bolezni živčevja Zelo pogosti: glavobol Redki: krči
• When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
• po prejemu novih informacij, ki lahko vplivajo na trenutne specifikacije varnosti zdravila,
Clinical studies in which a version of Focetria containing HA derived from A/Vietnam/1194/2004 (H5N1) was administered at day 1 and at day 22 provide:
Iz kliničnih študij, v katerih je bila na dan 0 in dan 22 uporabljena različica cepiva Focetria s HA pridobljenim iz A/Vietnam/1194/2004 (H5N1), so na voljo:
Focetria is a vaccine to prevent influenza (flu) caused by A(H1N1v) 2009 virus.
Kaj je cepivo FOCETRIA in za kaj ga uporabljamo Cepivo Focetria je cepivo za preprečevanje gripe, ki jo povzroča virus A(H1N1v) 2009.
Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), and a type of paralysis known as Guillain-Barré Syndrome.
Nevrološke motnje, kot so encefalomielitis (vnetje osrednjega živčevja)in vrsta paralize, znana kot Guillain-Barréjev sindrom.
Data on co-administration of Focetria H1N1v with a non-adjuvanted seasonal influenza subunit vaccine in healthy adults aged 18-60 years of age did not suggest any interference in the immune response to Focetria.
Podatki, pridobljeni pri sočasni uporabi cepiva Focetria H1N1v s cepivom proti sezonski gripi brez adjuvansa pri zdravih odraslih v starostni skupini 18-60 let ne kažejo pomembnega vpliva na imunski odziv na cepivo Focetria.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/385/004
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/385/004
Children (3-8 years)
Otroci (3 do 8 let)
It is provided in: - a ready-to-use syringe, containing a single dose of 0.5 ml for injection; - vial containing ten doses of 0.5 ml each for injection.
Na voljo je v: - pripravljeni injekcijski brizgi, ki vsebuje en odmerek 0,5 ml za injiciranje; - vsebniku z desetimi odmerki z 0,5 ml za injiciranje.
The same study demonstrated that previous administration of adjuvanted or unadjuvanted seasonal influenza vaccines to adults and elderly does not interfere with the immune response to Focetria.
Ista študija je pokazala, da predhodno cepljenje s sezonskimi cepivi proti gripi z ali brez adjuvansa pri odraslih osebah in starostnikih ne kaže pomembnega vpliva na imunski odziv na cepivo Focetria.
Focetria H1N1v may be co-administered with a non adjuvanted seasonal influenza vaccine.
Cepivo Focetria H1N1v se lahko uporabi skupaj s sezonskim cepivom proti gripi brez adjuvansa.
Seroprotection rate (95% CI)
Stopnja serološke zaščite (95-% IZ)
The vaccine should not be administered intravascularly.
Cepiva se ne sme dajati intravaskularno.
Headache, dizziness, somnolence, syncope.
Glavobol, omotičnost, somnolenca, sinkopa.
• Studies in adults and elderly
• Študije z odraslimi in starostniki
• Post-marketing surveillance
• Nadzor v obdobju trženja zdravila
In addition, from Post-marketing surveillance with seasonal trivalent vaccines in all age groups and with the MF59 adjuvanted seasonal trivalent vaccine with the similar composition of Focetria (surface antigen, inactivated, adjuvanted with MF59C.1), licensed for use in elderly subjects above 65 years of age, the following adverse events have been reported:
Poleg tega so v nadzoru sezonskih trivalentnih cepiv v obdobju trženja v vseh starostnih skupinah in sezonskih trivalentnih cepiv z adjuvansom MF59, katerih sestava je bila podobna cepivu Focetria (površinski antigen, inaktivirano cepivo, z adjuvansom MF59C.1), ki so bila odobrena za uporabo pri starostnikih nad 65 let, so poročali o naslednjih neželenih učinkih:
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER Medicinal product subject to medical prescription.
• POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
Focetria should under no circumstances be administered intravascularly.
Cepivo Focetria se v nobenem primeru ne sme dajati intravaskularno.
• Safety and immunogenicity data obtained after administration of one or two doses of Focetria H1N1v to healthy children and adolescents aged 6 months-17 years and to healthy adults, including the elderly.
• Podatki o varnosti in imunogenosti, dobljeni tri tedne po uporabi enega ali dveh odmerkov cepiva Focetria H1N1v pri zdravih otrocih in mladostnikih v starosti 6 mesecev-17 let in zdravih odraslih oseb, vključno s starostniki.
Excipients: thiomersal
Pomožne snovi: tiomersal
Uncommon (affects 1 to 10 users in 1,000): Flu like symptoms
Občasni (pojavijo se pri 1 do 10 cepljenih osebah od 1.000 cepljenih oseb): gripi podobni simptomi
In clinical trials with different formulations (H5N3, H9N2 and H5N1) approximately 3400 subjects were exposed to the mock-up vaccines.
V kliničnih preskušanjih z različnimi oblikami (H5N3, H9N2 in H5N1) je bilo modelnim cepivom izpostavljenih približno 3400 oseb.
Total N=66
Skupno n = 66
This may include the provision by the MAH of stickers with invented name and batch number with each pack of the vaccine.
V okviru teh ukrepov lahko imetnik dovoljenja za promet z zdravilom zagotovi nalepke z imenom cepiva in številko serije za vsako pakiranje cepiva.
Vial containing ten doses (0.5 ml each) for injection:
Viala z 10 odmerki (vsak po 0,5 ml) za injiciranje:
Adults and elderly
Odrasli in starostniki
Cardiac disorders Palpitation, tachycardia.
Srčne bolezni Palpitacija, tahikardija.
Infants (6 to 11 months of age)
Dojenčki (stari 6 do 11 mesecev)
Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Focetria alone.
Sočasne uporabe ni spremljal večji delež lokalnih ali sistemskih reakcij kot uporaba cepiva Pandemrix samega.
Total N=117
Skupno n = 117
• Safety and immunogenicity data in healthy children and adolescents aged from 6 months to 17 years and in adults, including the elderly
• Podatke o varnosti in imunogenosti za zdrave otroke in mladostnike v starosti od 6 mescev do 17 let ter odrasle osebe, vključno s starostniki.
Clinical studies with Focetria H1N1v currently provide:
Iz kliničnih študij s cepivom Focetria H1N1v so trenutno na voljo:
5.0 ml in 10-dose vial (type I glass) with stopper (halo-butyl rubber).
5,0 ml v viali z desetimi odmerki (steklo vrste I) z zamaškom (halobutilna guma).
(Manufacturer responsible for monovalent pooled harvests, before final filtration): Novartis Vaccines and Diagnostics S.r.l.
(Izdelovalec, odgovoren za monovalentne zbrane pridelke, pred končnim filtriranjem): Novartis Vaccines and Diagnostics S.r.l.
Muscoskeletal, connective tissue and bone disorders Muscular weakness, pain in extremities.
Bolezni mišično-skeletnega sistema in vezivnega tkiva Mišična oslabelost, bolečina v udih.
Based on the findings of an observational study conducted in >2000 pregnant women, reflecting the use of Focetria in pregnant women, influenza A (H1N1) vaccination with Focetria does not seem to be associated with an increased risk of adverse pregnancy outcomes, especially in the second or third trimesters of pregnancy.
Upoštevajoč poročilo PRAC o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za cepivo Focetria je odbor PRAC sprejel naslednje znanstvene zaključke: Na podlagi rezultatov opazovalne študije uporabe cepiva Focetria pri nosečnicah, opravljene pri >2000 nosečnicah, izgleda, da cepljenje proti influenci A (H1N1) s cepivom Focetria ni povezano z večjim tveganjem neželenih izidov nosečnosti, zlasti v drugem in tretjem trimesečju nosečnosti.
Skin and subcutaneous tissue disorders Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Bolezni kože in podkožja Generalizirane kožne reakcije, vključno s pruritusom, urtikarijo ali neznačilnim izpuščajem; angioedem.
Muscoskeletal, connective tissue and bone disorders Very common: myalgia
Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo pogosti: mialgija
Therefore the data indicate that Focetria may be co-administered with non adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
Podatki torej kažejo, da je mogoče cepivo Focetria uporabiti hkrati s cepivi proti sezonski gripi brez adjuvansa (vendar je cepivi treba injicirati v različni okončini).
Focetria contains
Cepivo Focetria vsebuje
Total N=120
Skupno n = 120
Elderly: A dose (0.5 ml) of the vaccine and a second dose of 0.5 ml at least three weeks later.
Starostniki: Prejmejo odmerek (0,5 ml) in drugi odmerek 0,5 ml ne prej kot tri tedne po prvem cepljenju.
Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Kako boste prejeli cepivo FOCETRIA Cepivo vam bo dal zdravnik ali medicinska sestra skladno z uradnimi priporočili.
One dose of 0.5 ml contains: Active Ingredients: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in eggs, and adjuvanted with MF59C.1, of strain:
En odmerek z 0,5 ml vsebuje: Zdravilne učinkovine: površinski virusni antigeni (hemaglutinin in nevraminidaza), razmnoženi v jajcih, z dodanim adjuvansom MF59C.1, seva:
PHARMACEUTICAL FORM AND CONTENTS Suspension for injection.
FARMACEVTSKA OBLIKA IN VSEBINA suspenzija za injiciranje
Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Nevrološke motnje kot so nevralgija, parestezija, konvulzije in nevritis.
Common (affects 1 to 10 users in 100): Bruising of the skin at the injection site, fever and nausea
Pogosti (pojavijo se pri 1 do 10 cepljenih osebah od 100 cepljenih oseb): modrice na koži na mestu injiciranja, vročina in siljenje na bruhanje
Blood and lymphatic system disorders Lymphadenopathy.
Bolezni krvi in limfatičnega sistema Limfadenopatija.
Total N=70
Skupno n = 70
Data in children and adolescents suggest a slight decrease in reactogenicity after the second dose of the vaccine, with no increase in rates of fever.
Podatki za otroke in mladostnike kažejo rahlo znižanje reaktogenosti po drugem odmerku cepiva brez zvišanja stopnje zvišane telesne temperature.
Children 6 months to 35 months:
Otroci od 6 do 35 mescev:
If you get any side effects, talk to your doctor or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali z medicinsko sestro.