FrancophonIA/ELRC3.0 huggingface dataset:
English: Encephalopathy within 7 days of administration of a previous dose of any vaccine containing pertussis antigens (whole cell or acellular pertussis vaccines).
Slovenian: Encefalopatija v 7 dneh po prejšnjem odmerku kateregakoli cepiva, ki vsebuje antigene pertusisa (cele celice ali acelularna cepiva proti oslovskemu kašlju).
English: NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
Slovenian: IME ZDRAVILA IN (ČE JE POTREBNO) POT(I) UPORABE ZDRAVILA HEXAVAC
English: The pertussis toxin (PT) is detoxified separately with glutaraldehyde to create the toxoid (PTxd).
Slovenian: Pertusis toksin (PT) se razstruplja ločeno z glutaraldehidom, pri čemer nastane toksoid (PTxd).
English: As each dose may contain undetectable traces of neomycin, streptomycin and polymyxin B, caution should be exercised when the vaccine is administered to subjects with hypersensitivity to these antibiotics.
Slovenian: Ker lahko vsak odmerek vsebuje nezaznavne sledove neomicina, streptomicina in polimiksina B, je potrebna previdnost pri cepljenju oseb s preobčutljivostjo za te antibiotike.
English: As with other vaccines your child may have some side effects.
Slovenian: Kot velja za vsa cepiva, se lahko pri vašem otroku pojavijo neželeni učinki.
English: Anti-poliovirus titres above the threshold of 5 (reciprocal of dilution in seroneutralisation) against poliovirus types 1, 2 and 3 were developed in 100 % of infants and these were considered protected against poliomyelitis.
Slovenian: Titri protiteles proti poliovirusom tipa 1, 2 in 3 nad vrednostjo praga 5 (recipročno redčenje pri seronevtralizaciji) so se razvili pri 100 % dojenčkov in zanje se smatra, da so zaščiteni proti otroški ohromelosti.
English: The covalent binding of PRP to tetanus toxoid makes it a T-cell dependent antigen which induces a specific IgG anti-PRP response in infants and which elicits immune memory.
Slovenian: S kovalentno vezavo PRP na tetanusni toksoid PRP postane od celic T odvisen antigen, kar sproži specifičen IgG odziv proti PRP pri dojenčkih in imunski spomin.
English: HEXAVAC has been generally well tolerated in clinical trials.
Slovenian: V kliničnih poskusih so otroci HEXAVAC na splošno dobro prenašali.
English: This leaflet was last approved on:
Slovenian: Navodilo je bilo odobreno:
English: Using other vaccines
Slovenian: Uporaba drugih zdravil
English: ** Surface antigen of hepatitis B virus produced from recombinant strain 2150-2-3 of the yeast
Slovenian: ** Površinski antigen virusa hepatitisa B proizvaja rekombinantni sev 2150-2-3 kvasovke
English: The diphtheria and tetanus toxoids are prepared from the toxins of cultures of Corynebacterium diphtheriae and Clostridium tetani by formaldehyde detoxification followed by purification.
Slovenian: Toksoid davice in tetanusni toksoid se pripravljata iz toksinov kultur Corynebacterium diphtheriae in Clostridium tetani s prečiščevanjem in razstrupljanjem s formaldehidom.
English: In the pivotal clinical study, all infants (100 %) developed a seroprotective antibody level (equal to or greater than 0.01 IU/ml) to both diphtheria and tetanus antigens one month after completion of the primary series.
Slovenian: V ključni klinični študiji so vsi dojenčki (100 %) razvili zaščitno raven protiteles (ne manj kot 0,01 i.e./ml) tako proti antigenom davice in antigenom tetanusa en mesec po zaključku programa primarnega cepljenja.
English: HEXAVAC should not be used as the birth dose or subsequent doses during the first year of life for children born to HbsAg-positive mothers .
Slovenian: HEXAVAC naj se ne uporablja za odmerek ob rojstvu ali za kasnejše odmerke v prvem letu življenja pri otrocih mater pozitivnih za HBsAg.
English: Take special care with HEXAVAC:
Slovenian: Bodite posebno pozorni pri uporabi HEXAVACa:
English: HEXAVAC will not prevent hepatitis infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E or by other liver pathogens.
Slovenian: HEXAVAC ne prepreči hepatitisnih okužb, ki jih povzročajo drugi povzročitelji, kot npr. virusi hepatitisa A, C in E ali drugi patogeni jeter.
English: Just before the booster injection anti-PRP GMTs were 0.40 µg/ml and 0.64 µg/ml for HEXAVAC and for the control group respectively.
Slovenian: Tik pred obnovitvenim odmerkom so bili GMT proti-PRP 0,40 µg/ml v skupini HEXAVAC in 0,64 µg/ml v kontrolni skupini.
English: Among reactions found at the injection site, itching and hives have been also reported.
Slovenian: Med reakcijami na mestu vbrizganja so poročali tudi o srbečici in izpuščajih.
English: Redness and/or induration > 7 cm at the injection site increased after booster immunisation but remained < 1 %.
Slovenian: Stopnja pojavnosti rdečine in/ali otekline > 7 cm na mestu vbrizganja je povečana pri poživitvenem cepljenju, vendar ostaja pod 1 %.
English: The vaccine may not prevent hepatitis B infection in such cases.
Slovenian: V takšnih primerih cepivo ne more preprečiti hepatitisa B.
English: Central and peripheral nervous system disorders: Convulsions (febrile and non febrile) / Encephalitis / Encephalopathy with acute brain oedema / Eyes rolling / Guillain Barré Syndrome / Hypotonia / Neuritis.
Slovenian: Bolezni centralnega in perifernega živčevja: krči (vročinski in nevročinski) / encefalitis / encefalopatija z akutnim edemom v možganih / vrtenje oči / sindrom Guillain Barré / hipotonija / Nevritis.
English: HEXAVAC does not protect against invasive diseases due to serotypes other than Haemophilus influenzae type b or against meningitis of other origins.
Slovenian: HEXAVAC ne ščiti pred invazivnimi okužbami, ki jih povzroči Haemophilus influenzae drugega tipa kot b ali pred meningitisom drugih izvorov.
English: The vaccine should not be mixed in the same syringe with other vaccines or parenterally administered substances.
Slovenian: To cepivo se v isti injekcijski brizgi ne sme mešati z drugimi cepivi ali drugimi zdravili za parenteralno uporabo.
English: Store at 2 °C - 8 °C (in a refrigerator).
Slovenian: Shranjujte pri temperaturi med 2°C - 8 °C (v hladilniku).
English: if any of the following events are known to have occurred in temporal relation to receipt of the vaccine (The decision to give further doses of pertussis-containing vaccines to your child should be carefully considered if any of the following events are known to have occurred following the administration of the vaccine) :
Slovenian: če se je pojavil katerikoli od naslednjih znakov v časovni povezavi s cepljenjem (Skrbno je potrebno pretehtati nadaljevanje cepljenja vašega otroka s cepivi, ki vsebujejo komponento proti oslovskemu kašlju, če se je pojavil katerikoli od naslednjih znakov po cepljenju):
English: Other side effects included irritability, sleepiness, fever, sleeplessness, diarrhoea, vomiting, loss of appetite and prolonged crying where the child cannot be consoled.
Slovenian: Drugi neželeni učinki so bili razdražljivost, zaspanost, vročina, nespečnost, driska, bruhanje, izguba teka in trajajoč neutolažljiv jok.
English: The surface antigen of hepatitis B virus is produced by culture of a recombinant strain of yeast cells (Saccharomyces cerevisiae).
Slovenian: Površinski antigen virusa hepatitisa B proizvaja rekombinantni sev kvasovk (Saccharomyces cerevisiae).
English: Name and address of the manufacturer of the biological active substances
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine(učinkovin)
English: Each 0.5 ml adjuvanted dose contains:
Slovenian: Vsak 0,5 mililitrski odmerek adsorbiranega cepiva vsebuje:
English: Following the booster dose, 96.6 % of toddlers developed anti-HBs titres equal to or greater than 10 mIU/ml.
Slovenian: Po obnovitvenem odmerku je 96,6 % malčkov razvilo titre protiHBs najmanj 10 mIU/ml.
English: Body as a whole - General disorders: Allergic reaction / Chills / Fatigue / Hypotonic-hyporesponsive episode / Malaise / Oedema / Pallor / Swelling or oedema of the entire limb(s) / Transient local lymph node swelling.
Slovenian: Telo kot celota - splošne težave: alergijska reakcija / mrazenje / utrujenost / hipotonična-hipoodzivna epizoda / splošna slabost /edem / bledica / otekanje ali edem celotnega uda(ov) / prehodno otekanje lokalnih limfnih vozljev.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE(UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: HEXAVAC is indicated to help protect your child against diphtheria, tetanus, pertussis, poliomyelitis, infection of the liver caused by all known subtypes of hepatitis B virus and invasive disease (infection of brain and spinal cord tissues, infection of the blood, etc.) caused by Haemophilus influenzae type b (Hib) bacterium in children 8 weeks to 18 months of age.
Slovenian: HEXAVAC je namenjen zaščiti vašega otroka proti davici, tetanusu, oslovskemu kašlju, otroški ohromelosti, okužbi jeter, ki jo povzročajo vsi znani podtipi virusa hepatitisa B in proti invazivni bolezni (okužbi možganov, tkiv hrbtenice, krvi, itn.), ki jo povzroča bakterija Haemophilus influenzae tipa b (Hib) bakterija pri otrocih starih od 8 tednov do 18 mesecev.
English: This vaccine induces specific humoral antibodies against HBsAg (anti-HBs) and against diphtheria and tetanus toxoids (anti-D and anti-T).
Slovenian: To cepivo sproži nastanek specifičnih humoralnih protiteles proti HBsAg (proti-HBs), proti davičnemu toksoidu (proti-D) in tetanusnemu toksoidu (proti-T).
English: Marketing Authorisation Holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon Manufactured by: Sanofi Pasteur SA, F-69280 Marcy l'Etoile
Slovenian: Imetnik dovoljenja za promet z zdravilom: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon Izdelovalec: Sanofi Pasteur SA, F-69280 Marcy l'Etoile
English: Sanofi Pasteur SA Campus Mérieux 1541 Avenue Marcel Mérieux F-69280 Marcy L'Etoile
Slovenian: Sanofi Pasteur SA Campus Merieux 1541 Avenue Marcel Mérieux F - 69280 Marcy L'Etoile
English: The acellular pertussis components (pertussis toxin: PT and filamentous haemagglutinin: FHA) are extracted from Bordetella pertussis cultures then separately purified.
Slovenian: Necelične komponente proti oslovskemu kašlju (pertusis toksin: PT in filamentozni hemaglutinin: FHA) so ekstrahirane iz kultur bakterije Bordetella pertussis in ločeno prečiščene.
English: This vaccine contains the purified capsular polysaccharide (polyribosyl ribitol phosphate: PRP) of Haemophilus influenzae type b conjugated to tetanus toxoid.
Slovenian: To cepivo vsebuje prečiščen kapsularni polisaharid (poliribozilribitol fosfat: PRP) bakterije Haemophilus influenzae tipa b, ki je konjugiran na tetanusni toksoid.
English: In the pivotal clinical study where toddlers received HEXAVAC as a booster dose after having been primed with HEXAVAC, antibody titres equal to or greater than 0.1 IU/ml were achieved by all toddlers to tetanus and by 98.8 % to diphtheria.
Slovenian: V ključni klinični študiji, kjer so malčki prejeli HEXAVAC kot obnovitveni odmerek po primarnem cepljenju s HEXAVAC-om, so titer najmanj 0,1 IU/ml dosegli vsi malčki proti tetanusu in 98,8 % malčkov proti davici.
English: The primary vaccination schedule consists of two or three doses of 0.5 ml administered within the first year of life according to the official recommendations.
Slovenian: Primarno cepljenje se po uradnih priporočilih izvede z dvema ali tremi odmerki po 0,5 ml v prvem letu življenja.
English: The immunogenicity of HEXAVAC could be reduced by immunosuppressive treatment or immunodeficiency.
Slovenian: Imunosupresivno zdravljenje ali imunska pomanjkljivost lahko zmanjšata imunogenost HEXAVAC-a.
English: The poliomyelitis vaccine is obtained from the propagation of poliomyelitis viruses types 1, 2 and 3 on Vero cells, purified, then inactivated by formaldehyde.
Slovenian: Cepivo proti otroški ohromelosti se pridobiva z razmnoževanjem virusov otroške ohromelosti tipov 1, 2 in 3 na celicah Vero, prečiščevanjem in inaktivacijo s formaldehidom.
English: HEXAVAC must not be mixed in the same syringe with other vaccines or other parenterally administered drugs.
Slovenian: HEXAVAC-a se v isti injekcijski brizgi ne sme mešati z drugimi cepivi ali drugimi zdravili za parenteralno uporabo.
English: Commonly reported reactions included redness and/or induration/swelling/pain at the injection site, fever equal to or greater than 38 °C, irritability, drowsiness, loss of appetite, insomnia, diarrhoea and vomiting.
Slovenian: Pogosto poročane reakcije so bile rdečina in/ali otrdlina/oteklina/bolečina na mestu vbrizganja, vročina ≥ 38 °C, razdražljivost, zaspanost, izguba teka, nespečnost, driska in bruhanje.
English: There are no data in regards to the efficacy and safety of concomitant administration of HEXAVAC with Measles, Mumps and Rubella Virus Vaccine, live.
Slovenian: Trenutno ni podatkov o učinkovitosti in varnosti sočasnega cepljenja s HEXAVAC-om in živimi cepivi proti ošpicami, mumpsu in rdečkami.
English: The rate of fever equal to or greater than 40 °C increased after booster immunisation but remained < 1 %.
Slovenian: Stopnja pojavnosti vročine ≥ 40 °C je povečana pri poživitvenem cepljenju, vendar ostaja pod 1 %.
English: Very rare reactions following the use of Sanofi Pasteur MSD hepatitis B (recombinant) vaccine include alopecia, hypotension, optic neuritis, facial paralysis, erythema multiforme, and anaphylaxis.
Slovenian: Zelo redke reakcije po cepljenju z rekombinantnim cepivom Sanofi Pasteur MSD proti hepatitisu B so bile alopecija, hipotenzija, optični nevritis, paraliza obraza, erythema multiforme in anafilaktična reakcija.
English: Less commonly, fever equal to or greater than 40 °C, tenderness at the injection site, prolonged inconsolable crying and redness and/or induration > 7 cm at the injection site or swelling of the entire limb have been reported.
Slovenian: Manj pogosto poročane reakcije so bile vročina ≥ 40 °C, občutljivost na mestu vbrizganja, trajajoč neutolažljiv jok in rdečina in/ali otrdlina > 7 cm na mestu vbrizganja ali otekanje celotnega uda.
English: HEXAVAC can be used for the booster dose provided the toddler has received a full primary vaccination course of each of the antigens contained in HEXAVAC regardless of whether they were administered as monovalent or combination vaccines produced by Sanofi Pasteur MSD.
Slovenian: HEXAVAC se lahko uporabi kot obnovitveni odmerek pod pogojem, da je malček prejel popolno primarno cepljenje za vsakega od antigenov, ki jih vsebuje HEXAVAC, ne glede ali so bili dani kot monovalentna ali kombinirana cepiva, ki jih proizvaja Sanofi Pasteur MSD.
English: Rarely, the patient may have prolonged or abnormal crying.
Slovenian: Redko se je pojavil trajajoč in nenormalen jok.
English: Before use, the vaccine should be well shaken in order to obtain a homogeneous slightly opaque white suspension.
Slovenian: 6.6 Navodila za pripravo in ravnanje z zdravilom Pred uporabo je potrebno cepivo dobro pretresti, da nastane homogena rahlo motno bela suspenzija.
English: MANUFACTURER'S BATCH NUMBER Batch
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Št. serije:
English: However, when HEXAVAC was co-administered in clinical studies the rate of febrile reactions was higher compared to that occurring following administration of hexavalent vaccines alone.
Slovenian: Vendar je bila v kliničnih poskusih sočasnega dajanja HEXAVAC-a stopnja febrilnih reakcij višja kot pri cepljenju samo s heksavalentnimi cepivi.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Sanofi Pasteur MSD SNC
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sanofi Pasteur MSD SNC
English: AntiPRP titres equal to or greater than 0.15 µg/ml and equal to or greater than 1 µg/ml were achieved in 100 % and 96.6 % of toddlers respectively.
Slovenian: Titre proti-PRP najmanj 0,15 µg/ml je doseglo 100 % malčkov, titre najmanj 1 µg/ml pa 96,6 % malčkov.
English: Before you use HEXAVAC 3.
Slovenian: Kaj morate vedeti, preden boste uporabili HEXAVAC 3.
English: Common (>1/100 and <1/10) Application site disorders (reactions at the injection site): Oedema / Pruritus / Urticaria.
Slovenian: Motnje na mestu uporabe (reakcije na mestu vbrizganja): edem / srbečica / urtikarija.
English: Development of anti-HBs titre equal to or greater than 10 mIU/ml and of anti-D and anti-T equal to or greater than 0.01 IU/ml measured 1-2 months after the third injection correlates with protection against hepatitis B infection and against diphtheria and tetanus respectively.
Slovenian: Razvoj titra proti-HBs ne manj kot 10 mIU/ml po 1-2 mesecih po tretjem odmerku cepiva korelira z zaščito proti okužbi z virusom hepatitisa B, razvoj titrov proti-D oz. proti-T na manj kot 0,01 i.e./ml v istem času pa korelira z zaščito proti davici in tetanusu.
English: if your child has any present or past medical problems or allergies, including allergic reactions if you are a hepatitis B virus surface antigen (HBsAg)-positive mother, your infant should receive Hepatitis B Immune Globulin (HBIG) and hepatitis B vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series.
Slovenian: če ima vaš otrok zdravstvene težave z alergijami trenutno ali jih je imel kadarkoli v preteklosti, vključno z alergijskimi reakcijami po kateremkoli odmerku HEXAVAC-a. če ste mati pozitivni za površinski antigen virusa hepatitisa B (HBsAg), bi moral vaš otrok ob rojstvu prejeti imunoglobulin proti virusu hepatitisa B (HBIG) in rekombinantno cepivo proti hepatitisu B, nato pa dokončati zaporedje cepljenj proti hepatitisu B. Dajanje HEXAVAC-a za dokončanje zaporedja cepljenj proti hepatitisu B pri novorojenčkih mater pozitivnih za HBsAg, ki so prejeli HBIG, in pri novorojenčkih mater neznanega statusa ni preučeno.
English: For pertussis, 91.8 % and 90.5 % of infants achieved a four-fold rise in PT and FHA antibody titres respectively.
Slovenian: Proti oslovskemu kašlju je 91,8 % dojenčkov razvilo štirikratno povečanje titra protiteles proti PT, 90,5 % pa enako povečanje protiteles proti FHA.
English: After a primary vaccination with 2 doses of HEXAVAC (i.e. 3, 5 months), a booster dose must be given between 11 and 13 months of age; after a primary vaccination with 3 doses of Hexavac (e.g. 2, 3, 4 months; 2, 4, 6 months), a booster dose must be given between 12 and 18 months of age, according to official recommendations.
Slovenian: Po uradnih priporočilih se mora pri primarnem cepljenju z 2 odmerkoma HEXAVAC-a (npr. 3. in 5. mesec) obnovitveno cepljenje izvesti med 11. in 13. mesecem življenja; po primarnem cepljenju s 3 odmerki HEXAVAC-a (npr. 2., 3. in 4. mesec; 2., 4. in 6. mesec) pa se mora obnovitveno cepljenje izvesti med 12. in 18. mesecem življenja.
English: A mean 20.5-fold rise in antibody titres to HBs was observed after the booster dose.
Slovenian: Po obnovitvenem odmerku je bilo opaženo v povprečju 20,5-kratno povečanje titrov protiteles proti HBs.
English: Skin and appendages disorders: Angioedema / Erythema / Pruritus / Rash / Urticaria .
Slovenian: Bolezni kože in priveskov: angioedem / rdečica / srbečica / izpuščaj / urtikarija.
English: Read all of this leaflet carefully before your child is vaccinated.
Slovenian: Preden je vaš otrok cepljen natančno preberite navodilo!
English: Immune response after booster injection
Slovenian: Imunski odziv po obnovitvenem odmerku
English: There are currently no sufficient data available regarding immunogenicity of the concomitant administration of HEXAVAC with PREVENAR (pneumococcal polysaccharide conjugated vaccine, adsorbed).
Slovenian: Trenutno ni na voljo dovolj podatkov glede imunogenosti sočasnega cepljenja s HEXAVAC-om in PREVENAR-jem (pnevmokokno polisaharidno konjugirano cepivo z adjuvansom).
English: Antipyretic treatment should be initiated according to local guidelines.
Slovenian: V skladu z lokalnimi smernicami se lahko prične z zdravljenjem za zmanjševanje vročine.
English: This combined vaccine is indicated for primary and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.
Slovenian: To kombinirano cepivo se uporablja za primarno in obnovitveno cepljenje otrok proti davici, tetanusu, oslovskemu kašlju, vsem znanim podtipom virusa hepatitisa B, otroški ohromelosti in invazivnim okužbam s Haemophilus influenzae tipa b.
English: The active substances are:
Slovenian: Zdravilne učinkovine so:
English: There are currently not sufficient data available regarding immune response of the concomitant administration of HEXAVAC with PREVENAR (pneumococcal polysaccharide conjugated vaccine, adsorbed).
Slovenian: Trenutno ni na voljo dovolj podatkov o imunskem odzivu pri sočasnem cepljenju s HEXAVAC-om in PREVENAR-jem (adsorbirano pnevmokokno polisaharidno konjugirano cepivo).
English: HEXAVAC should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Slovenian: Pri dajanju HEXAVAC-a osebam s trombocitopenijo ali motnjo krvavitve je potrebna previdnost, saj se lahko pri teh osebah razvije krvavitev kot posledica intramuskularnega odmerjanja.
English: if your child has fever or other illness, particularly a cough, cold or flu (vaccination should be delayed).
Slovenian: če ima vaš otrok vročino ali drugo obolenje, predvsem kašelj, prehlad ali gripo (cepljenje naj se če je vaš dojenček utrpel možganske poškodbe (encefalopatijo) po prejšnjem odmerku celičnega ali neceličnega cepiva proti oslovskemu kašlju.
English: Do not freeze
Slovenian: Ne zamrzujte!
English: Platelets, bleeding & clotting disorders: Petechiae / Purpura / Purpura thrombocytopenic / Thrombocytopenia.
Slovenian: Motnje trombocitov, krvavitev in strjevanja: petehije / purpura / trombocitopenična purpura / trombocitopenija.
English: However when HEXAVAC was co-administered with PREVENAR (pneumococcal polysaccharide conjugated vaccine, adsorbed) in clinical studies, the rate of febrile reactions was higher compared to that occurring following the administration of hexavalent vaccines alone.
Slovenian: Vendar je bila v kliničnih poskusih sočasnega dajanja HEXAVAC-a in PREVENAR-ja (pnevmokoknega polisaharidnega konjugiranega cepiva z adjuvansom) stopnja febrilnih reakcij višja kot pri cepljenju samo s heksavalentnimi cepivi.
English: SPECIAL STORAGE CONDITIONS Store at 2 °C - 8 °C (in a refrigerator) Do not freeze
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi med 2°C - 8 °C (v hladilniku).
English: Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of immunisation.
Slovenian: Zaradi dolge inkubacijske dobe hepatitisa B, je možno, da je v času cepljenja prisotna nezaznavna okužba z virusom hepatitisa B. V takšnih primerih cepivo ne more preprečiti okužbe z virusom hepatitisa B.
English: Side effects included injection-site reactions such as tenderness, redness, swelling and pain.
Slovenian: Med neželene učinke so spadale reakcije ne mestu vbrizganja, kot npr. občutljivost, rdečina, otekanje in bolečine.
English: 96.6 % of infants ; the geometric mean titres (GMTs) were diminished compared to the control group.
Slovenian: Zaščitne ravni proti-HBs (ne manj kot 10 mi.e./ml) so bile dosežene pri 96,6 % dojenčkov; titri geometričnega povprečja (GMT) so bili zmanjšani v primerjavi s kontrolno skupino.
English: After a primary vaccination with 2 doses of HEXAVAC (e.g 3, 5 months), a booster dose must be given between 11 and 13 months of age; after a primary vaccination with 3 doses of Hexavac (e.g. 2, 3, 4 months; 2, 4, 6 months), a booster dose must be given between 12 and 18 months of age, according to official recommendations.
Slovenian: 3. in 5. mesec) obnovitveno cepljenje izvesti med 11. in 13. mesecem življenja; po primarnem cepljenju s 3 odmerki HEXAVAC-a (npr. 2., 3. in 4. mesec; 2., 4. in 6. mesec) pa se mora obnovitveno cepljenje izvesti med 12. in 18. mesecem življenja.
English: Gastro-intestinal system disorders: Abdominal pain / Meteorism / Nausea.
Slovenian: Bolezni prebavil: bolečine v trebuhu / meteorizem / slabost.