natgillin/translations-raw huggingface dataset:
• Hepatitis B: Infection with the hepatitis B virus may cause the liver to become swollen (inflamed).
• Hepatitis B: Okužba z virusom hepatitisa B lahko povzroči oteklino jeter (vnetje).
• a degenerative disease of the brain (encephalopathy)
• degenerativna možganska bolezen (encefalopatija),
In situations where a booster dose of hepatitis A and/or hepatitis B is desired, a monovalent or combined vaccine can be given.
V okoliščinah, ko je zaželen obnovitveni odmerek cepiva proti hepatitisu A in/ali hepatitisu B, se lahko cepi z monovalentnim ali s kombiniranim cepivom.
In 2 comparative trials in subjects aged 1-15 years, the incidences of local and general solicited symptoms after a two dose regimen of Ambirix was overall similar to that seen with the three dose combined vaccine containing 360 ELISA Units of HAV and 10 µg of HBsAg.
V 2 primerjalnih preskušanjih pri otrocih, starih od 1 do 15 let, so bile incidence lokalnih in splošnih nespontano evidentiranih simptomov po shemi z dvema odmerkoma cepiva Ambirix v celoti podobne kot po uporabi treh odmerkov kombiniranega cepiva, ki je vsebovalo 360 ELISA-enot HAV in 10 µg HBsAg.
- Hepatitis A virus (inactivated) 1,2
-Virus hepatitisa A (inaktivirani)1,2
Rare: arthralgia
Redki: artralgija.
• paralysis, drooping eyelid and sagging muscles on one side of the face (facial palsy)
• paraliza, spuščena veka in mlahave mišice na eni strani obraza (paraliza obraza),
However, it is sometimes caught in other ways, such as by swimming in water that has sewage in it or from another infected person.
Do okužbe običajno pride s hrano ali pijačo, ki vsebuje virus, lahko pa se prenaša tudi na druge načine, na primer s plavanjem v vodi, ki je onesnažena s fekalijami ali preko okužene osebe.
INFORMATION IN BRAILLE Justification for not including Braille accepted.
Sprejeta je utemeljitev, da Braillova pisava ni potrebna
• If you have any further questions, ask your doctor, nurse or pharmacist.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Immune system disorders Allergic reactions including mimicking serum sickness, angioneurotic oedema
Alergijske reakcije, vključno s takšnimi, ki so podobne serumski bolezni, angionevrotični edem.
Ambirix should only be used during breast-feeding when the possible advantages outweigh the potential risks.
Cepivo Ambirix se sme med obdobjem dojenja uporabiti le, če možne koristi odtehtajo možna tveganja.
1 dose (1 ml)
1 odmerek (1 ml)
In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titers may not be obtained after the primary immunisation course.
Pri bolnikih na hemodializi in osebah z oslabljenim imunskim sistemom je možno, da po zaključku osnovnega cepljenja niso doseženi primerni titri protiteles anti-HAV in anti-HBs.
The percentages with anti-HBs antibody ≥10 mIU/ml at this time point for subjects aged 1-11 years or 12-15 years at the time of the first dose were 77.3% and 85.9%, respectively.
Delež protiteles anti-HBs ≥10 mi.e./ml je bil pri osebah, starih ob prvem cepljenju od 1 do 11 let ali 12 do 15 let, ob tem času 77,3 % pri prvih in 85,9 % pri drugih.
• generally feeling unwell
• splošno slabo počutje,
EXPIRY DATE EXP: MM/YYYY
EXP: MM/LLLL
What Ambirix looks like and contents of the pack
Izgled cepiva Ambirix in vsebina pakiranja
Adverse reactions reported following overdosage were similar to those reported with normal vaccine administration.
opisani po prevelikem odmerjanju, so bili podobni kot po normalni uporabi cepiva.
The safety and immunogenicity of Ambirix administered as a booster dose following a two dose primary course have not been evaluated.
Varnost in imunogenost obnovitvenega odmerka cepiva Ambirix, danega po že prejetih dveh odmerkih v času osnovnega cepljenja, nista bili ovrednoteni.
- Hepatitis B surface antigen 3,4
-Površinski antigen virusa hepatitisa B3,4
They are called hepatitis B “carriers” and can still infect other people throughout their lives.
Imenujejo se klicenosci virusa hepatitisa B in lahko ves čas življenja prenašajo virus hepatitisa B na druge.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reactions following the administration of the vaccine.
Tako kot pri vseh cepivih za injiciranje je zaradi možnih redkih primerov anafilaktične reakcije po aplikaciji treba vedno razpolagati s takojšnjim ustreznim zdravljenjem in nadzorom.
However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins there was no effect on seroconversion rates.
Kljub temu pa sočasno dajanje monovalentnih cepiv proti hepatitisu A in hepatitisu B ter specifičnih imunoglobulinov ni vplivalo na odstotek serokonverzije.
The holder of marketing authorisation will continue to submit annual PSURs.
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Imetnik dovoljenja za promet z zdravilom bo periodična poročila o varnosti zdravila (PSUR) še naprej predajal letno.
Ambirix confers immunity against HAV and HBV infection by inducing specific anti-HAV and antiHBs antibodies.
Mehanizem delovanja Ambirix zagotavlja imunost proti okužbi s HAV in HBV tako, da inducira tvorbo specifičnih anti
In both studies, subjects received either a two dose schedule of Ambirix or a three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
V obeh študijah so osebe prejele bodisi cepivo Ambirix po shemi dveh odmerkov bodisi tri odmerke kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B.
In clinical studies involving subjects from 1 year up to and including 15 years old, seropositivity rates for anti-HAV antibodies were 99.1% one month after the first dose and 100% after the second dose given at month 6 (i.e month 7).
V kliničnih študijah, v katere so bile vključene osebe, stare od 1 do vključno 15 let, je bil en mesec po prejemu prvega odmerka odstotek seropozitivnosti za protitelesa anti-HAV 99,1 %, po prejemu drugega odmerka čez 6 mesecev (npr. 7. mesec) pa 100 %.
• inflammation of the nerves (neuritis)
• vnetje živcev (nevritis),
• disease of the nerves of the eyes (optic neuritis)
• bolezen vidnega živca (optični nevritis),
• swelling or infection of the brain (encephalitis)
• otekanje ali okužba možganov (encefalitis),
The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver.
Cepivo ne bo preprečilo okužb z drugimi povzročitelji, kot sta virus hepatitisa C in virus hepatitisa E,
• immediate injection site pain, stinging and burning feeling
• takojšnja bolečina na mestu vboda, občutek zbadanja in pekoč občutek,
If you are taking medicines that affect your body's immune response, you can still have Ambirix if this is thought to be necessary.
Če jemljete zdravila, ki vplivajo na imunski odziv, lahko kljub temu prejmete cepivo Ambirix, če se zdi to potrebno, vendar cepivo morda ne bo delovalo popolnoma.
Following widespread use of either GlaxoSmithKline's combined hepatitis A and hepatitis B vaccines or the monovalent hepatitis A and/or hepatitis B vaccines, the following adverse reactions have additionally been reported.
Po široki uporabi kombiniranih cepiv družbe GlaxoSmithKline proti hepatitisu A in hepatitisu B ali njenih monovalentnih cepiv proti hepatitisu A in/ali hepatitisu B so bili dodatno opisani naslednji neželeni učinki.
• Hepatitis A: Infection with the hepatitis A virus may cause the liver to become swollen (inflamed).
• Hepatitis A: Okužba z virusom hepatitisa A lahko povzroči oteklino jeter (vnetje).
Blood and lymphatic system disorders Thrombocytopenic purpura, thrombocytopenia
Bolezni krvi in limfatičnega sistema Trombocitopenična purpura, trombocitopenija.
Infections and infestations Meningitis
Infekcijske in parazitske bolezni Meningitis.
A dose of 1.0 ml is recommended for subjects from 1 year up to and including 15 years of age.
Priporočen odmerek za od 1 do vključno 15 let stare osebe je 1,0 ml.
Concomitant vaccines should always be administered at separate injection sites and preferably into different limbs.
V primeru sočasnega dajanja je cepiva potrebno vedno aplicirati na ločena mesta, najboljše v drugo okončino.
After a few days they may be very tired, and have dark urine, pale faeces, yellowish skin or eyes (jaundice).
Po nekaj dneh so lahko zelo utrujeni, imajo temen urin, svetlo blato,
LIST OF EXCIPIENTS Sodium chloride Water for injections
natrijev klorid voda za injiciranje
Talk to your doctor, nurse or pharmacist before having Ambirix if:
Posvetujte se z zdravnikom, medicinsko sestro ali farmacevtom, preden se cepite s cepivom Ambirix,
In subjects aged 12-15 years at primary vaccination the anti-HAV and anti-HBs antibody concentrations were comparable between groups that had received Ambirix or a 3-dose regimen of the combined vaccine (content as described above).
Koncentracije protiteles anti-HAV in anti-HBs so bile pri osebah, starih ob prvem cepljenju od 12-15 let, primerljive s skupino, ki je prejela cepivo Ambirix, in skupino, ki je prejela 3 odmerke kombiniranega cepiva (vsebnost je opisana zgoraj).
Nervous system disorders Syncope or vasovagal responses to injection, localised hypoaesthesia
Sinkopa ali vazovagalni odziv na injekcijo, omejena hipestezija.
If you are not sure, talk to your doctor, nurse or pharmacist before having Ambirix.
Če niste prepričani, se pogovorite z zdravnikom, medicinsko sestro ali farmacevtom, preden se cepite s cepivom Ambirix.
Pack sizes of 1 and 10 pre-filled syringes with or without needles and pack size of 50 pre-filled syringes without needles.
Velikost pakiranja: po 1 in 10 napolnjenih injekcijskih brizg z injekcijskimi iglami ali brez njih ter po 50 napolnjenih injekcijskih brizg brez injekcijskih igel.
It is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit).
Virus se nahaja v telesnih tekočinah, kot so kri, sperma, nožnični izločki ali slina (izpljunki).
If any of the above apply (or you are not sure), talk to your doctor, nurse or pharmacist before having Ambirix.
Če za vas velja karkoli od zgoraj naštetega (oziroma ste negotovi), se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom pred cepljenjem s cepivom Ambirix.
This leaflet was last revised in {month YYYY}
Navodilo je bilo nazadnje revidirano dne Drugi viri informacij
1-5 yrs old
1-5 let
Carriers are also at risk of serious liver problems, such as scarring (cirrhosis) or liver cancer.
Pri klicenoscih virusa hepatitisa B obstaja tveganje za resne težave z jetri, kot sta brazgotinjenje jeter (ciroza) in rak jeter.
When the first dose of Ambirix was administered concomitantly with a booster dose of a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV+Hib) or with the first dose of a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory.
Če se je prvi odmerek cepiva Ambirix dal sočasno z obnovitvenim odmerkom mešanega cepiva proti davici, tetanusu, oslovskemu kašlju - acelularno, otroški ohromelosti - inaktivirano in Haemophilusu influenzae tipa b (DTPa-IPV+Hib) ali s prvim odmerkom mešanega cepiva proti ošpicam, mumpsu in rdečkam v drugem letu življenja, so bili imunski odzivi na vse antigene zadovoljivi.
• inflammation of some blood vessels (vasculitis)
• vnetje nekaterih žil (vaskulitis),
• flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills
• gripi podobni simptomi, npr. zvišana telesna temperatura, vnetje žrela, izcedek iz nosu,
What you need to know before you receive Ambirix
Kaj morate vedeti, preden boste prejeli cepivo Ambirix Cepiva Ambirix ne smete prejeti:
Seropositivity rates for anti-HBs antibodies were 74.2% one month after the first dose and 100% after the second dose given at month 6 (i.e. month 7).
En mesec po prejemu prvega odmerka je bil odstotek seropozitivnosti za protitelesa anti-HBs 74,2 %, po prejemu drugega odmerka čez 6 mesecev (npr. 7. mesec) pa 100 %.
• reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia),
• zmanjšanje števila krvnih ploščic, ki poveča tveganje za krvavitve ali podplutbe (trombocitopenija), vijoličaste ali rdečerjave pike, vidne skozi kožo (trombocitopenična purpura).
At 6 years following the initiation of a 0, 6 month or a 0, 12 month schedule of Ambirix in children aged 12-15 years all subjects followed up retained ≥15 mIU/ml anti-HAV antibody.
6 let po cepljenju otrok, starih od 12 do 15 let, s cepivom Ambirix po shemi 0., 6. mesec ali 0., 12. mesec so vse osebe ohranile ≥15 mi.e./ml protiteles anti-HAV.
General disorders and administration site conditions Very common: fatigue, pain and redness at the injection site Common: fever, swelling at the injection site
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: utrujenost, bolečina in pordelost na mestu injiciranja.
Immune system disorders Allergic reactions including anaphylactic and anaphylactoid reactions
Alergijske reakcije, vključno z anafilaktično in anafilaktoidno reakcijo.
Skin and subcutaneous tissue disorders Rare: pruritus, rash
Bolezni kože in podkožja Redki: srbenje, izpuščaj.
Side effects that occurred during routine use of Ambirix were as follows:
Med rutinsko uporabo cepiva Ambirix so se pojavili naslednji neželeni učinki:
Infections and infestations Uncommon: upper respiratory tract infection
Občasni: okužba zgornjih dihal.
In addition, the following adverse reactions were reported during clinical trials with GlaxoSmithKline's other combined hepatitis A and hepatitis B vaccines (given as a 3 or 4 dose schedule)
Poleg tega so bile med kliničnimi preskušanji drugih kombiniranih cepiv družbe GlaxoSmithKline proti hepatitisu A in hepatitisu B (uporabljenih v 3 ali 4 odmerkih) opisani naslednji neželeni učinki.
The following adverse reactions were reported during clinical trials with Ambirix.
Naslednji neželeni učinki so se pojavili pri kliničnih preskušanjih s cepivom Ambirix:
How to store Ambirix
Shranjevanje cepiva Ambirix
month schedules were 84.8% and 92.9%, respectively.
92,9 % pri drugih.
• swollen glands in the neck, armpit or groin (lymphadenopathy)
• otekle bezgavke na vratu, v pazduhah ali dimljah (limfadenopatija),
If rapid protection against hepatitis B is required, the standard three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen is recommended.
V primeru potrebe po hitri zaščiti pred hepatitisom B je priporočljiva standardna shema treh odmerkov kombiniranega cepiva z vsebnostjo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B. V vmesnem obdobju med prejemom drugega in tretjega odmerka kombiniranega cepiva bo tako zaščiten večji odstotek oseb, kot je po enem samem odmerku cepiva Ambirix.
United Kingdom GlaxoSmithKline UK Tel: +44 (0)800 221 441 customercontactuk@gsk.com
United Kingdom GlaxoSmithKline UK Tel: +44 (0)800 221 441
In a comparative clinical trial conducted among subjects aged from 12 years up to and including 15 years of age, 142 received two doses of Ambirix and 147 received the standard three-dose combined vaccine.
15 let, jih je 142 prejelo dva odmerka cepiva Ambirix, 147 pa jih je prejelo standardno cepivo s tremi odmerki.
Ambirix is indicated in non-immune children and adolescents from 1 year up to and including 15 years of age for protection against hepatitis A and hepatitis B infection.
Cepivo Ambirix je indicirano za zaščito pred okužbo z virusom hepatitisa A in okužbo z virusom hepatitisa B pri neimuniziranih otrocih in mladostnikih od 1 do vključno 15 let starosti.
When Ambirix was administered concomitantly with, but as a separate injection to a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV+Hib) or with a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory (see section 5.1).
oslovskemu kašlju - acelularno, otroški ohromelosti - inaktivirano in Haemophilusu influenzae tipa b (DTPa-IPV+Hib) ali mešanega cepiva proti ošpicam, mumpsu in rdečkam v drugem letu življenja, je bil imunski odziv na vse antigene zadovoljiv (glejte poglavje 5.1).
Ambirix should not be given if any of the above apply.
S cepivom Ambirix se ne smete cepiti, če velja karkoli od zgoraj naštetega.
Skin and subcutaneous tissue disorders Erythema multiforme, lichen planus
Multiformni eritem, lichen planus.
2D barcode carrying the unique identifier included.
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznak 18.
HAB vaccine
Žilne bolezni
For the 289 subjects evaluable for immunogenicity, seroprotection rates (SP in the table below) against hepatitis B were significantly higher at months 2 and 6 with the three-dose vaccine than with Ambirix.
Slednje je vsebovalo 360 ELISA enot s formalinom inaktiviranega virusa hepatitisa A in 10 mikrogramov rekombinantnega površinskega antigena virusa hepatitisa B. Pri 289 osebah, pri katerih je bila ovrednotena imunogenost, je bil v 2. in 6. mesecu odstotek serozaščite (SP v spodnji tabeli) proti hepatitisu B signifikantno višji po cepljenju s tremi odmerki cepiva kot pa po cepljenju s cepivom Ambirix.
Very common (These may occur with more than 1 in 10 doses of the vaccine) :
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 odmerkov cepiva):
• fits or seizures
Bolezni kože in podkožja
GlaxoSmithKline AS Tlf: + 47 22 70 20 00 firmapost@gsk.no
Tlf: + 47 22 70 20 00 firmapost@gsk.no
• numbness or weakness of the arms and legs (neuropathy)
• omrtvičenost ali šibkost rok in nog (nevropatija),
Musculoskeletal and connective tissue disorders Arthritis, muscular weakness
Artritis, mišična šibkost.
• Clinical trial data
• Podatki iz kliničnih preskušanj
General disorders and administration site conditions Immediate injection site pain, stinging and burning sensation
Splošne težave in spremembe na mestu aplikacije Takojšnja bolečina na mestu vboda, občutek zbadanja in pekoč občutek.
Blood and lymphatic system disorders Rare: lymphadenopathy
Bolezni krvi in limfatičnega sistema
Vaccine group
Skupina glede na cepljenje
Hepatitis A virus (inactivated)1,2
1 odmerek (1 ml): Virus hepatitisa A (inaktivirani)1,2
No data on concomitant administration of Ambirix with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Podatki o sočasnem dajanju cepiva Ambirix in specifičnih imunoglobulinov proti hepatitisu A ali imunoglobulinov proti hepatitisu B niso bili pridobljeni.
Contents of the pack and other information
Shranjevanje cepiva Ambirix Vsebina pakiranja in dodatne informacije
It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination.
Možno je, da so osebe v času cepljenja že v inkubacijskem obdobju okužbe s hepatitisom A ali hepatitisom B. Ni znano, če v takšnih primerih cepivo Ambirix preprečuje hepatitis A in hepatitis B.
Cases of overdose with GlaxoSmithKline's combined hepatitis A and hepatitis B vaccine have been reported during post-marketing surveillance.
Med obdobjem postmarketinškega spremljanja so bili opisani primeri prevelikega odmerjanja kombiniranega cepiva proti hepatitisu A in hepatitisu B družbe GlaxoSmithKline.
Hepatobiliary disorders Abnormal liver function tests
Nenormalni testi jetrne funkcije.
• abnormal test results relating to the liver
• nenormalni izvidi preiskav jeter,
PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in pre-filled syringe 1 pre-filled syringe
Suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga 1 odmerek (1 ml)
Additional side effects that occurred during routine use of very similar combined or individual hepatitis A and hepatitis B vaccines were as follows:
Med rutinsko uporabo zelo podobnih kombiniranih ali enokomponentnih cepiv proti hepatitisu A in hepatitisu B so poročali o naslednjih dodatnih neželenih učinkih:
• aching muscles (myalgia)
• okužba zgornjih dihal, • boleče mišice (mialgija).
Your doctor will run blood tests to see whether more injections are needed to help you be better protected.
To pomeni, da morda ne boste zaščiteni proti enemu ali obema virusoma hepatitisa A in B. Vaš zdravnik bo izvedel krvne preiskave, da bi ugotovil, ali so potrebne dodatne injekcije, ki bi pomagale, da bi bili bolje zaščiteni.
Additional side effects that have been reported during clinical trials with very similar combined hepatitis A and hepatitis B vaccines, include:
Med kliničnimi preskušanji z zelo podobnimi kombiniranimi cepivi proti hepatitisu A in hepatitisu B so poročali o naslednjih dodatnih neželenih učinkih:
Missing a dose
Izpuščeni odmerek
• If you/your child gets any side effects, talk to your doctor, nurse or pharmacist.
• Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
How much is given
Koliko cepiva se uporabi
• Ambirix may not protect you from being ill if you have already caught the hepatitis A or B virus.
• Cepivo Ambirix vas morda ne bo zaščitilo pred boleznijo, če ste se že okužili z virusom hepatitisa A ali B. • Cepivo Ambirix vas lahko pomaga zaščititi le pred okužbo z virusom hepatitisa A ali B, ne more pa preprečiti drugih okužb jeter, čeprav so lahko znaki teh okužb podobni tistim pri okužbi z virusom hepatitisa A ali B.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid voda za injekcije
Tel: + 43 1 970 75-0 at.info@gsk.com
Tel. +370 5 264 90 00 info.lt@gsk.com
1330 Rixensart
1330 Rixensart Belgija
NAME OF THE MEDICINAL PRODUCT Ambirix - Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Ambirix - suspenzija za injiciranje v napolnjeni injekcijski brizgi Cepivo proti hepatitisu A, inaktivirano, in hepatitisu B, rekombinantno (HAB), adsorbirano
Protection against hepatitis B infections may not be obtained until after the second dose (see section Therefore: - Ambirix should be used only when there is a relatively low risk of hepatitis B infection during the vaccination course.
- Ambirix se lahko uporablja le, če je tveganje za okužbo z virusom hepatitisa B med potekom cepljenja relativno majhno.
General disorders and administration site conditions Common: malaise, injection site reaction Rare: chills, influenza like illness
Splošne težave in spremembe na mestu aplikacije Pogosti: splošno slabo počutje, reakcija na mestu injiciranja.
The anti-hepatitis B surface antigen (anti-HBs) and anti-hepatitis A virus (anti-HAV) antibody titres observed following a primary vaccination course with Ambirix are in the range of what is seen following vaccination with the monovalent hepatitis A and B vaccines.
Po zaključku osnovnega cepljenja s cepivom Ambirix so doseženi titri protiteles proti površinskemu antigenu virusa hepatitisa B (anti-HBs) in proti virusu hepatitisa A (anti-HAV) primerljivi s tistimi, ki se jih doseže po cepljenju z monovalentnimi cepivi proti hepatitisu A in hepatitisu B. Splošne smernice za obnovitveno cepljenje se torej lahko povzamejo iz izkušenj z monovalentnimi cepivi, kot sledi:
Metabolism and nutrition disorders
Infekcijske in parazitske bolezni
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 August 2002
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
The percentages with anti-HBs antibody ≥10 mIU/ml at this time point for subjects vaccinated at the 0, 6 and 0, 12
Delež protiteles anti-HBs ≥10 mi.e./ml je bil pri osebah, cepljenih po shemi 0., 6. mesec ali 0., 12. mesec, ob tem času 84,8 % pri prvih in
50 x 1 dose (1 ml)
50 napolnjenih injekcijskih brizg 50 x 1 odmerek (1 ml)