natgillin/translations-raw huggingface dataset:
In the two clinical trials in which Twinrix Adult was administered at 0, 7, 21 days, overall solicited general and local symptoms were reported with the same categories of frequency as defined below.
U dva klinička ispitivanja u kojima je Twinrix Adult primijenjen po shemi 0., 7., 21. dan, opći i lokalni simptomi su sveukupno prijavljeni u istoj kategoriji učestalosti, kako je niže definirana.
It is important that procedures are in place to avoid injury from faints.
Važno je na adekvatan način provoditi cijepljenje kako bi se izbjegle ozljede prilikom pada u nesvijest.
Multiple sclerosis, myelitis, facial palsy, polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), optic neuritis
Poremećaji živčanog sustava multipla skleroza, mijelitis, paraliza lica, polineuritis poput Guillain-Barréova sindroma (s ascendentnom paralizom), optički neuritis
Additional doses may need to be considered for persons who do not respond or have a suboptimal response to a course of vaccinations.
Treba razmotriti primjenu dodatnih doza u osoba koje nakon završenog cijepljenja nisu odgovorile ili je njihov odgovor suboptimalan.
• Loss of skin sensitivity to pain or touch (hypoaesthesia)
• gubitak osjeta boli ili dodira na koži (hipoestezija)
• Degenerative disease of the brain (encephalopathy)
• degenerativna bolest mozga (encefalopatija)
PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in pre-filled syringe 1 pre-filled syringe
OBLIK I SADRŽAJ Suspenzija za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka
In two long term clinical studies conducted in adults aged 17 years to 43 years, 56 subjects had evaluable tests 15 years after the primary vaccination with Twinrix Adult; the anti-HAV seropositivity rates were 100% in both studies and the anti-HBs seroprotection rates were 89.3% and 92.9%, respectively.
U dva dugotrajna klinička ispitivanja provedena u odraslih osoba starosti 17 do 43 godine, 56 ispitanika imalo je ocjenjiv test 15 godina nakon primarnog cijepljenja cjepivom Twinrix Adult; antiHAV stope seropozitivnosti bile su 100 % u oba ispitivanja, dok su anti-HBs stope seropozitivnosti bile 89,3% odnosno 92,9%.
Seropositivity rates for anti-HAV antibodies were 100%, 99.5% and 100% at months 1, 2 and 3 after the initial dose.
Stope seropozitivnosti za anti-HAV protutijela su bile 100%, 99,5% i 100%, 1, 2 odnosno 3 mjeseca nakon prve doze.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLE 25 PRE-FILLED SYRINGES WITHOUT NEEDLE 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 25 PRE-FILLED SYRINGES WITH 25 NEEDLES
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU 1 NAPUNJENA ŠTRCALJKA BEZ IGLE 10 NAPUNJENIH ŠTRCALJKI BEZ IGLE 25 NAPUNJENIH
• Drooping eyelid and sagging muscles on one side of the face (facial palsy)
• spušteni očni kapak i mišići jedne strane lica (paraliza lica)
The kinetics of decline of anti-HAV and anti-HBs antibodies were shown to be similar to those of the monovalent vaccines.
Pokazalo se da je kinetika opadanja anti-HAV i anti-HBs protutijela slična kao kod monovalentnih cjepiva.
• Serious allergic reactions (anaphylaxis, anaphylactoid reactions and mimicking serum sickness).
• ozbiljne alergijske reakcije (anafilaksija, anafilaktoidne reakcije i one koje oponašaju serumsku bolest).
• Flu-like symptoms such as high temperature, sore throat, runny nose, cough and chills
• simptomi nalik gripi, kao što su visoka temperatura, grlobolja, curenje nosa, kašalj i zimica
The recommended schedule should be adhered to. Once initiated, the primary course of vaccination should be completed with the same vaccine.
Jednom započeto, primarno cijepljenje treba dovršiti istim cjepivom.
Twinrix Adult should under no circumstances be administered intravascularly.
Twinrix Adult se ni u kom slučaju ne smije primijeniti intravaskularno.
Do not use this medicine after the expiry date which is stated on the carton.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake „EXP“.
When re-suspended, the vaccine will have a uniform hazy white appearance.
Nakon resuspendiranja cjepivo će biti jednolično mutno bijelog izgleda.
For some categories of subjects or patients exposed to HBV (e.g; haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure a protective antibody level ≥ 10IU/l.
Za neke kategorije osoba ili bolesnika izloženih virusu HBV (npr. bolesnici na hemodijalizi ili imunokompromitirani), treba osigurati da im razina protutijela bude jednaka ili iznad zaštitne razine od 10 IU/l.
In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titres may not be obtained after the primary immunisation course and such patients may therefore require administration of additional doses of vaccine.
Može se dogoditi da bolesnici na hemodijalizi te osobe s oslabljenim imunološkim sustavom nakon primarne imunizacije ne razviju adekvatan titar anti-HAV i anti-HBs protutijela, te će stoga u takvih bolesnika možda biti potrebno primijeniti dodatne doze cjepiva.
Angioneurotic oedema, lichen planus, erythema multiforme
Poremećaji kože i potkožnog tkiva angioneurotski edem, lichen planus, multiformni eritem
• First dose:
• Prva doza:
It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.
Za očekivati je da se u bolesnika pod imunosupresivnom terapijom te bolesnika s oslabljenim imunološkim sustavom možda neće postići adekvatan odgovor.
The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Prije primjene cjepivo treba vizualno pregledati zbog moguće prisutnost bilo kakvih stranih čestica i/ili abnormalnog fizičkog izgleda.
• Generally feeling unwell
• opće loše osjećanje
• Swelling or infection of the brain (encephalitis)
• oticanje ili infekcija mozga (encefalitis)
This disease is caused by the hepatitis A virus.
Ova je bolest izazvana virusom hepatitisa A. Virus hepatitisa
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.
Cjepivo neće spriječiti zarazu uzrokovanu drugim uzročnicima poput virusa hepatitisa C, hepatitisa E
In a clinical study conducted in subjects over 40 years of age, the seropositivity rate for anti-HAV antibodies and seroprotection rate against hepatitis B of Twinrix Adult following a 0, 1, 6 months schedule were compared with the seropositivity and seroprotection rates of monovalent hepatitis A and B vaccines when administered in opposite arms.
U kliničkom ispitivanju provedenom na ispitanicima iznad 40-te godine života, stopa seropozitivnosti za anti-HAV protutijela i stopa seroprotekcije protiv hepatitisa B, postignutih nakon cijepljenja cjepivom Twinrix Adult po shemi 0, 1, 6 mjeseci, uspoređivani su sa seropozitivnosti i stopama seroprotekcije nakon monovalentnih cjepiva protiv hepatitisa
It is not known whether Twinrix Adult will prevent hepatitis A and hepatitis B in such cases.
Nije poznato hoće li u tom slučaju Twinrix Adult spriječiti obolijevanje od hepatitisa A, odnosno hepatitisa B.
As indicated in section 2, a poor response to the vaccine, possibly without achieving protection against hepatitis B, is more common in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some type of drug treatments.
Kao što je već navedeno u dijelu 2. smanjen odgovor na cjepivo, vjerojatno bez postizanja zaštite protiv hepatitisa B češći je kod starijih osoba, kod muškaraca više nego kod žena, pušača, pretilih osoba i osoba s dugotrajnim bolestima, ili osoba koje su na nekoj vrsti liječenja.
Twinrix Adult contains neomycin Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic).
Molimo recite svom liječniku ako ste ikad imali alergijsku reakciju na neomicin (antibiotik).
In the event of either being observed, do not administer the vaccine.
U slučaju da ste uočili nešto od navedenog, cjepivo nemojte primijeniti.
It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination.
Moguće je da osobe u vrijeme cijepljenja budu u periodu inkubacije infekcije hepatitisa
It is not known if Twinrix Adult passes into breast milk, however the vaccine is not expected to cause problems in breast-fed babies.
Nije poznato izlučuje li se Twinrix Adult u majčino mlijeko, no ne očekuju se problemi od cjepiva u dojene djece.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GlaxoSmithKline Biologicals s.a.
Repeat this action vigorously for at least 15 seconds.
Ponavljajte ovu radnju snažno tijekom najmanje 15 sekundi 4. Ponovno provjerite izgled cjepiva:
Exceptionally the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
Iznimno se cjepivo može primijeniti supkutano u bolesnika s trombocitopenijom ili poremećajima hemostaze.
Stinging and burning sensation
Osjećaj peckanja i žarenja
Hepatitis B surface antigen3,4
720 ELISA jedinica površinski antigen virusa hepatitisa B 3,4
• Purple or red brown spots visible through the skin (thrombocytopenic purpura)
• ljubičaste ili crveno-smeđe točkice po koži (trombocitopenična purpura)
• Hepatitis B: Hepatitis B is caused by the hepatitis B virus.
• Hepatitis B: Hepatitis B uzrokuje virus hepatitisa B, koji dovodi do oteknuća jetre (upale).
• Multiple sclerosis, swelling of the spinal cord (myelitis)
• multipla skleroza, oticanje kralježnične moždine (mijelitis)
The kinetics of antibody decline are also similar.
Slična je i kinetika opadanja protutijela.
It is unknown whether Twinrix Adult is excreted in human breast milk.
Nije poznato izlučuje li se Twinrix Adult u majčino mlijeko u ljudi.
Subjects received an additional dose of the same vaccine(s) 48 months after the first dose of the primary vaccination course.
Ispitanici su 48 mjeseci nakon prve doze primarnog ciklusa cijepljenja primili dodatnu dozu istog (istih) cjepiva.
Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness
Poremećaji imunološkog sustava anafilaksija, alergijske reakcije, uključujući anafilaktoidne reakcije i one koje oponašaju serumsku bolest
• Abnormal laboratory liver test results
• abnormalni nalazi pretraga funkcije jetre
The administration of Twinrix Adult should be postponed in subjects suffering from acute severe febrile illness.
Primjenu cjepiva Twinrix Adult treba odgoditi u osoba oboljelih od teže akutne bolesti praćene vrućicom.
• Third dose:
• Treća doza:
0.05 milligrams Al3+ 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology Adsorbed on aluminium phosphate
0,05 miligrama Al3+ 3 proizveden tehnologijom rekombinantne DNK na stanicama kvasca (Saccharomyces cerevisiae) 4 adsorbiran na aluminijev fosfat
The effect of Twinrix Adult on embryo-fetal, peri-natal and post-natal survival and development has not been prospectively evaluated in clinical trials.
Učinak cjepiva Twinrix Adult na embrio-fetalno, perinatalno i postnatalno preživljenje i razvoj nije bilo prospektivno praćeno u kliničkim ispitivanjima.
Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided.
Treba izbjegavati intradermalno injiciranje ili intramuskularnu primjenu u glutealni mišić jer ti putevi primjene mogu rezultirati suboptimalnim odgovorom na cjepivo.
Cases of overdose have been reported during post-marketing surveillance.
Tijekom praćenja nakon stavljanja cjepiva u promet zabilježeni su slučajevi predoziranja.
In comparative studies, it was noted that the frequency of solicited adverse events following the administration of Twinrix Adult is not different from the frequency of solicited adverse events following the administration of the monovalent vaccines.
U komparativnim ispitivanjima zabilježeno je da se učestalost nuspojava koje se javljaju nakon primjene cjepiva Twinrix Adult ne razlikuje od učestalosti nuspojava koje se javljaju nakon primjene monovalentnih cjepiva.
The seroprotection rate against hepatitis B after the administration of Twinrix Adult was 92% and 56% at 7 and 48 months respectively, versus 80% and 43% after the GlaxoSmithKline Biologicals monovalent 20µg hepatitis B vaccine, and 71% and 31% after another licensed monovalent 10µg hepatitis B vaccine.
Stopa seroprotekcije protiv hepatitisa B nakon primjene cjepiva Twinrix Adult je iznosila 92% nakon 7 mjeseci i 56% nakon 48 mjeseci, naspram 80% odnosno 43% nakon primjene GlaxoSmithKline Biologicals monovalentnog 20 µg cjepiva protiv hepatitisa B, te 71% odnosno 31% nakon primjene jednog drugog monovalentnog 10 µg odobrenog cjepiva protiv hepatitisa B.
The most commonly reported adverse reactions following Twinrix Adult administration with the standard 0, 1, 6 month schedule are pain and redness occurring in a per dose frequency of 37.6% and 17.0% respectively.
Twinrix Adult pri standardnoj shemi od 0, 1, i 6 mjeseci su bol i crvenilo, koje se javljaju s učestalošću po dozi od 37,6% odnosno 17,0%.
The seropositivity rate for anti-HAV antibodies after Twinrix Adult was 97% at both 7 and 48 months versus 99% and 93% after the GlaxoSmithKline Biologicals monovalent hepatitis A vaccine and 99% and 97% after another licensed monovalent hepatitis A vaccine.
Stopa seropozitivnosti za anti-HAV protutijela nakon primjene cjepiva Twinrix Adult je iznosila 97% i nakon 7 i nakon 48 mjeseci, naspram 99% odnosno 93% nakon primjene GlaxoSmithKline Biologicals monovalentnog cjepiva protiv hepatitisa A, te 99% odnosno 97% nakon primjene jednog drugog monovalentnog cjepiva protiv hepatitisa A.
MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a. rue de l'Institut 89
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GlaxoSmithKline Biologicals s.a. rue de l'Institut 89
Uncommon Vomiting, abdominal pain*
mučnina manje često povraćanje, bol u abdomenu*
Abnormal liver function tests * refers to adverse reactions observed in clinical trials performed with the paediatric formulation
*odnosi se na nuspojave zamijećene u kliničkim ispitivanjima provedenima s pedijatrijskim oblikom cjepiva
A poor response to the vaccine, possibly without achieving protection against hepatitis A, has been observed in obese people.
U pretilih je osoba zamijećen slab odgovor na cjepivo, te je moguće ne postići zaštitu od hepatitisa A.
A poor response to the vaccine, possibly without achieving protection against hepatitis B, has also been observed in older people, men rather than women, smokers, obese people, and people with long standing illnesses, or people on some type of drug treatments.
Ustanovljen je i slab odgovor na cjepivo, bez postizanja zaštite protiv hepatitisa B, u starijih osoba, kod muškaraca više nego kod žena, pušača, pretilih osoba, onih s kroničnim bolestima ili osoba na nekim tipovima liječenja.
• Feeling of pins and needles (paraesthesia)
• osjećaj trnaca i bockanja (parestezije)
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKIH DJELATNIH TVARI I PROIZVOĐAČ ODGOVORANZA
If you have any further questions on the use of this vaccine, ask your doctor or pharmacist.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog cjepiva, obratite se svom liječniku ili ljekarniku.
Upon storage, a fine white deposit with a clear colourless layer above may be observed.
Stajanjem može doći do pojave finog bijelog taloga s bistrim bezbojnim supernatantom.
LIST OF EXCIPIENTS Sodium chloride Water for injections
6.1 Popis pomoćnih tvari natrijev klorid voda za injekcije
Alternatively, subjects primed with Twinrix Adult may be administered a booster dose of either of the monovalent vaccines.
Alternativno, u osoba koje su primarno cijepljene cjepivom Twinrix Adult za docjepljivanje se može primijeniti monovalentno cjepivo.
Twinrix Adult is indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.
Twinrix Adult indiciran je za primjenu u neimunih odraslih osoba i adolescenata od navršene 16. godine života koji su pod rizikom od zaraze i hepatitisom
• Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme), hives
• ljubičaste ili crvenkasto-ljubičaste izbočine na koži (lichen planus), ozbiljan kožni osip
The effect of Twinrix Adult on embryo-fetal, peri-natal and post-natal survival and development has been assessed in rats.
Učinak cjepiva Twinrix Adult na embrio-fetalno, perinatalno i postnatalno preživljenje i razvoj procjenjivan je na štakorima.
Side effects occurred very rarely during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines include:
Nuspojave koje su se javile vrlo rijetko tijekom kliničkih ispitivanja ili rutinske primjene ovog cjepiva ili monovalentnih cjepiva protiv hepatitisa
In the clinical studies, specific humoral antibodies against hepatitis A were observed in approximately 94% of the adults one month after the first dose and in 100% one month after the third dose (i.e. month 7).
A utvrđena su u približno 94% odraslih osoba mjesec dana nakon prve doze, te u 100% njih mjesec dana nakon treće doze (tj. mjesec 7).
How Twinrix Adult is given
Kako se primjenjuje Twinrix Adult
swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Znakovi ozbiljne alergijske reakcije mogu biti osip koji može svrbjeti ili imati mjehuriće, oticanje očiju i lica, otežano disanje ili gutanje, nagli pad krvnog tlaka ili gubitak svijesti.
3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
3 proizveden tehnologijom rekombinantne DNK na stanicama kvasca (Saccharomyces cerevisiae) 4 adsorbiran na aluminijev fosfat
How to store Twinrix Adult
Kako čuvati Twinrix Adult
Twinrix Adult has no or negligible influence on the ability to drive and use machines.
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Twinrix Adult ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Swelling at the injection site, injection site reactions (such as haematoma, pruritus and bruising), malaise Uncommon Fever (≥ 37.5°C) Rare
Opći poremećaji i reakcije na mjestu primjene vrlo često bol i crvenilo na mjestu injiciranja, umor često oticanje na mjestu injiciranja, reakcije na mjestu injiciranja (poput hematoma, pruritusa i modrica), malaksalost manje često vrućica (≥ 37,5°C)
The remaining 2 doses will be given 7 days and 21 days after the first dose.
Prva doza će se dati odabranog datuma, druga doza 7 dana kasnije, te treća 21 dan nakon prve doze.
• Joint swelling, muscular weakness
• oticanje zglobova, slabost mišića
Side effects that may occur are the following:
Učestalosti pojavljivanja definirane su kao:
The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline monovalent hepatitis A or B vaccines:
Sljedeće su nuspojave prijavljene nakon primjene cjepiva Twinrix ili monovalentnih cjepiva protiv hepatitisa
Re-suspension of the vaccine to obtain a uniform hazy white suspension
Resuspendiranje cjepiva kako bi se dobila jednolična mutno bijela suspenzija.
Hepatitis A virus (inactivated)1,2
TVARI 1 doza (1 ml) sadrži: inaktivirani virus hepatitisa A 1,2
No data on concomitant administration of Twinrix Adult with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Nema podataka o istodobnoj primjeni cjepiva Twinrix Adult i specifičnih imunoglobulina protiv hepatitisa
These consist of nausea (feeling sick), fever and aches and pains.
Simptomi uključuju mučninu, vrućicu i bolove.
A fourth dose is recommended at 12 months.
Preporučuje se dati četvrtu dozu cjepiva 12 mjeseci nakon prve.
Rash, pruritus
• osip, svrbež
The remaining two doses will be given one month, and six months after the first dose.
Prva doza će se dati odabranog datuma, druga mjesec dana kasnije, a treća šest mjeseci nakon prve doze.
However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins, no influence on seroconversion was observed although it may result in lower antibody titres.
A i hepatitisa B sa specifičnim imunoglobulinima, nije opažen utjecaj na serokonverziju,
1 pre-filled syringe + 1 needle 1 dose (1 ml)
1 napunjena štrcaljka + 1 igla 1 doza (1 ml)
Make sure you finish the complete vaccination course of three injections.
Vodite računa o tome da primite cjelokupni slijed cijepljenja od 3 injekcije, inače nećete biti u potpunosti zaštićeni od bolesti.
In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix Adult can be given.
A i protiv hepatitisa B, može se dati Twinrix
b. If the vaccine still does not appear as a uniform hazy white suspension - tip upside down and back again for at least another 15 seconds - then inspect again.
b. Ako cjepivo još uvijek ne izgleda kao jednolično mutno bijela suspenzija-ponovno protresite okrećući ga naopako i vraćajući ga u početni položaj za najmanje dodatnih
25 pre-filled syringes + 25 needles 25 x 1 dose (1 ml)
25 napunjenih štrcaljki + 25 igala 25 x 1 doza (1 ml)
Very rare (These may occur in up to 1 in 10,000 doses of the vaccine):
Vrlo rijetke (mogu se pojaviti u do 1 na 10 000 doza cjepiva):
1 month later
• Druga doza: 1 mjesec kasnije
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava rijetko limfadenopatija
The anti-HBs and anti-HAV antibody titres observed following a primary vaccination course with the combined vaccine are in the range of what is seen following vaccination with the monovalent vaccines.
Titri anti-HBs i anti-HAV protutijela utvrđeni nakon primarnog cijepljenja kombiniranim cjepivom u rasponu su titara utvrđenih nakon cijepljenja monovalentnim cjepivima.
Water for injections
natrijev klorid voda za injekcije
Influenza like illness, chills
rijetko bolest nalik gripi, zimica
• Swelling, bruising or itching at the injection site
• oticanje, modrica ili svrbež na mjestu uboda
In a clinical trial where Twinrix Adult was administered according to this schedule, 82% and 85% of vaccinees had seroprotective levels of anti-HBV antibodies at 1 and 5 weeks respectively following the third dose (i.e. at months 1 and 2 after the initial dose).
Adult primijenjen po tom rasporedu, 82% cijepljenika dostiglo je seroprotektivnu razinu protutijela protiv HBV tjedan dana nakon treće doze, a 85% njih 5 tjedana nakon treće doze (tj. 1 odnosno 2
Inspect the vaccine again: a. If the vaccine appears as a uniform hazy white suspension, it is ready to use - the appearance should not be clear.
Ako cjepivo izgleda kao jednolično mutno bijela suspenzija, spremno je za primjenuizgled ne smije biti bistar.
7 days later
• Druga doza: 7 dana kasnije
- The other ingredients in Twinrix Adult are: sodium chloride, water for injections.
0,4 miligrama Al3+ - Drugi sastojci u cjepivu Twinrix Adult su: natrijev klorid, voda za injekcije.
12 months after the first dose Your doctor will advise on the possible need for extra doses, and future booster dosing.
Vaš liječnik će Vas savjetovati jesu li potrebne dodatne doze ili buduće docjepljivanje.
• Inflammation of nerves (neuritis)
• upala živaca (neuritis)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Twinrix Adult, suspension for injection
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Twinrix Adult, suspenzija za injekciju HAB cjepivo i.m.
• Vomiting, stomach pain
• povraćanje, bolovi u trbuhu • bolovi u mišićima
Long-term antibody persistence data following vaccination with Twinrix Adult are available up to 15 years after vaccination.
Postoje dugoročni podaci o perzistenciji protutijela nakon cijepljenja cjepivom Twinrix Adult do
Clinical trials Infections and infestations
Infekcije i infestacije meningitis