natgillin/translations-raw huggingface dataset:
Infanrix hexa has been administered to more than 1000 preterm infants (born after a gestation period of 24 to 36 weeks) in primary vaccination studies and in more than 200 preterm infants as a booster dose in the second year of life.
Cepivo Infanrix hexa je bilo uporabljeno pri več kot 1000 nedonošenčkih (rojenih po gestacijski starosti od 24 do 36 tednov) v študijah primarnega cepljenja in pri več kot 200 nedonošenčkih kot obnovitveni odmerek v drugem letu življenja.
weeks N= 265 (1 study)
tednov N = 265 (1 študija)
Pertactin (PRN)1
25 mikrogramov pertaktin (PRN)1
Infanrix hexa is contraindicated if the infant or toddlers has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.
Uporaba cepiva Infanrix hexa je kontraindicirana, če je dojenček ali otrok prebolel encefalopatijo neznanega vzroka, ki se je pojavila v sedmih dneh po predhodnem cepljenju s cepivom, ki je vsebovalo tudi komponento proti oslovskemu kašlju.
• Infanrix hexa helps your child's body make its own protection (antibodies).
Kako cepivo Infanrix hexa deluje • Cepivo Infanrix Hexa pomaga telesu vašega otroka ustvariti lastno zaščito (protitelesa).
The immunogenicity of Infanrix hexa was evaluated across three studies including approximately 300 preterm infants (born after a gestation period of 24 to 36 weeks) following a 3-dose primary vaccination course at 2, 4 and 6 months of age.
Imunogenost cepiva Infanrix hexa so ocenili v treh študijah, ki so zajele približno 300 nedonošenčkov (rojenih po gestacijski starosti od 24 do 36 tednov), po primarnem cepljenju s tremi odmerki v starosti 2, 4 in 6 mesecev.
• if your child tends to have fits when they have a fever, or if there is a history of this in the family.
• če je vaš otrok nagnjen h krčem, ko ima zvišano telesno temperaturo ali pa so se ti pojavljali v družini;
Powder in a vial (type I glass) with a stopper (butyl).
Prašek v viali (steklo tipa I) z zamaškom iz butilne gume.
Infanrix hexa, Powder and suspension for suspension for injection.
Infanrix hexa, prašek in suspenzija za suspenzijo za injiciranje.
As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrix hexa with respect to the primary course.
Kot pri DTPa-cepivu in kombiniranih cepivih, ki vsebujejo DTPa, so poročali o povečanem pojavu lokalnih reakcij in zvišane telesne temperature po aplikaciji obnovitvenega odmerka cepiva Infanrix hexa v primerjavi z osnovnim cepljenjem.
Infanrix hexa will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Cepivo Infanrix hexa ne prepreči bolezni, ki jih povzročijo drugi patogeni, ne pa Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, virus hepatitisa B, poliovirus ali Haemophilus influenzae tipa b. Vendar je mogoče pričakovati, da bo cepljenje preprečilo hepatitis D, kajti hepatitis D (ki ga povzroča agens delta) se ne pojavi, če ni okužbe s hepatitisom B.
Less commonly, the bacteria can also infect the blood, heart, lungs, bones, joints, and tissues of the eyes and mouth.
Manj pogosto povzroči tudi okužbo krvi, srca, pljuč, kosti, sklepov in očesnih in ustnih sluznic.
Your doctor may ask you to give your child a medicine that lowers fever (such as paracetamol) before or immediately after Infanrix hexa is given.
Zdravnik vam bo morda naročil, da otroku pred cepljenjem ali takoj po cepljenju s cepivom Infanrix hexa date zdravilo za znižanje zvišane telesne temperature (vročine) (kot npr. paracetamol).
• Both components are mixed together just before your child receives the injection.
• Tik preden bo vaš otrok prejel odmerek, bodo obe komponenti pomešali skupaj.
• Not all pack sizes may be marketed.
• Na trgu morda ni vseh navedenih pakiranj.
8 D-antigen unit type 3 (Saukett strain)4
8 D-antigenskih enot tip 3 (sev Saukett) 4
The following drug-related adverse reactions were reported in clinical studies (data from more than 16,000 subjects) and during post-marketing surveillance.
V kliničnih študijah (podatki pridobljeni pri več kot 16.000 preiskovancih) in v obdobju trženja so poročali o naslednjih s cepivom povezanih neželenih učinkih.
Country Schedule Vaccine efficacy
Država Shema cepljenja
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 VIAL AND 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 VIALS AND 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 1 VIAL AND 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 VIALS AND 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
1 VIALA IN 1 NAPOLNJENA INJEKCIJSKA BRIZGA BREZ INJEKCIJSKE IGLE 10 VIAL IN 10 NAPOLNJENIH INJEKCIJSKIH BRIZG BREZ IGEL 1 VIALA IN 1 NAPOLNJENA INJEKCIJSKA BRIZGA Z 2 IGLAMA 10 VIAL IN 10 NAPOLNJENIH INJEKCIJSKIH BRIZG Z 20 IGLAMI
Powder and suspension for suspension for injection.
Prašek in suspenzija za suspenzijo za injiciranje.
The lyophilised Haemophilus influenzae type b (Hib) component is a white powder.
Komponenta Haemophilus influenzae tipa b (Hib) je bel liofiliziran prašek.
Other medicines and Infanrix hexa
Druga zdravila in cepivo Infanrix hexa
Whooping cough can also cause ear infections, chest infections (bronchitis) which may last a long time, lung infections (pneumonia), fits, brain damage and even death.
Oslovski kašelj lahko povzroči vnetje ušes, vnetje v prsnem košu (bronhitis), ki je lahko dolgotrajno, vnetje pljuč (pljučnico), krče, poškodbe možganov in celo smrt.
(≥1/1,000 to <1/100)
(≥ 1/1.000 do < 1/100)
months N= 1055 (6 studies)
mesecev N = 1055 (6 študij)
• This vaccine has been prescribed for your child only.
• Cepivo je bilo predpisano vašemu otroku in ga ne smete dajati drugim.
The other ingredients are:
Aktivne sestavine so:
In extremely rare cases the following side effects have been reported with hepatitis B vaccine: paralysis, numbness or weakness of the arms and legs (neuropathy), inflammation of some nerves, possibly with pins and needles or loss of feeling or normal movement (Guillain-Barré syndrome), swelling or infection of the brain (encephalopathy, encephalitis), infection around the brain (meningitis).
V zelo redkih primerih so bili v povezavi s cepivom proti hepatitisu B poročani naslednji neželeni učinki: paraliza, otrplost ali šibkost rok in nog (nevropatija), vnetje nekaterih živcev, lahko z mravlinčenjem ali izgubo občutka ali normalnega gibanja (Guillain-Barrejev sindrom), oteklost ali okužba možganov (encefalopatija, encefalitis), okužba okrog možganov (meningitis).
Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap by twisting it anticlockwise.
Z eno roko držite valj brizge (ne bata brizge) in odvijte pokrovček brizge, tako da ga zasučete v smeri, nasprotni urnemu kazalcu.
Medium 199 containing principally amino acids, mineral salts, vitamins Water for injections
brezvodna laktoza natrijev klorid medij 199, ki vsebuje predvsem aminokisline, mineralne soli, vitamine voda za injekcije
• There should be an interval of at least 2 months between primary doses.
• Med primarnima odmerkoma morata miniti vsaj 2 meseca.
Very common (these may occur with more than 1 in 10 doses of the vaccine): feeling tired, loss of appetite, high temperature of 38°C or higher, swelling, pain, redness where the injection site was given, unusual crying, feeling irritable or restless.
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 odmerkov cepiva): občutek utrujenosti, izguba apetita, zvišana telesna temperatura 38 °C ali več, oteklost, bolečina, pordelost na mestu injiciranja, nenavadno jokanje, občutek razdražljivosti ali nemirnosti.
Other side effects include:
Ostali neželeni učinki so:
The effectiveness of the Hib component of Infanrix hexa was investigated via an extensive postmarketing surveillance study conducted in Germany.
Obširna študija postmarketinškega spremljanja učinkovitosti komponente cepiva Infanrix hexa proti Hib je bila izvedena v Nemčiji.
HIV infection is not considered as a contraindication.
Okužbe z virusom humane imunske pomanjkljivosti (HIV) ne prištevamo h kontraindikacijam.
Poliovirus (inactivated) (IPV) type 1 (Mahoney strain)4
10 mikrogramov poliovirus (inaktivirani) (IPV) tip 1 (sev Mahoney) 4
N = number of subjects * Samples tested by ELISA to have anti-diphtheria antibody concentrations < 0.1 IU/ml were re-tested using Vero-cell neutralisation assay (seroprotection cut-off ≥ 0.016 IU/ml): 96.5% of the subjects were seroprotected § Number of subjects from 2 clinical studies
N = število preiskovancev * Vzorce, ki so imeli z ELISA koncentracijo protiteles proti davici < 0,1 i.e./ml, so ponovno testirali z uporabo nevtralizacijskega preizkusa z Vero-celicami (mejna vrednost serološke zaščite
Data from one clinical study indicate that when Infanrix hexa is co-administered with MMRV vaccine, the rate of febrile reactions is higher compared to that occurring following the administration of Infanrix hexa alone and similar to that occurring following the administration of MMRV vaccine alone (see sections 4.4 and 4.8).
Podatki ene klinične študije kažejo, da je delež febrilnih reakcij po uporabi cepiva Infanrix hexa skupaj s cepivom MMRV večji, kot če je cepivo Infanrix hexa uporabljeno samo, in podoben tistemu po uporabi cepiva MMRV samega (glejte poglavji 4.4 in 4.8).
Common (these may occur with up to 1 in 10 doses of the vaccine): diarrhoea, being sick (vomiting), high temperature of more than 39.5°C, swelling larger than 5 cm or hard lump where the injection was given, feeling nervous.
Pogosti (pojavijo se lahko pri največ 1 od 10 odmerkov cepiva): driska, bruhanje, zvišana telesna temperatura nad 39,5 °C, več kot 5 cm velika oteklina ali trda bula na mestu injiciranja, občutek živčnosti.
Nervousness
vznemirjenost
MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
IMETNIK DOVOLJENJA ZA PROMET GlaxoSmithKline Biologicals s.a.
• if your child has had an allergic reaction to any vaccine against diphtheria, tetanus, whooping cough, hepatitis B, polio or Haemophilus influenzae type b.
• če je kdaj imel alergijsko reakcijo na katerokoli cepivo proti davici, tetanusu, oslovskemu kašlju, hepatitisu B, otroški paralizi ali Haemophilus influenzae tipa b;
Hib powder: lactose anhydrous
Hib prašek: brezvodna laktoza
Powder and suspension for suspension for injection in a pre-filled syringe Vial: powder
prašek in suspenzija za suspenzijo za injiciranje v napolnjeni injekcijski brizgi viala: prašek napolnjena injekcijska brizga: suspenzija
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Intramuscular use
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo za intramuskularno uporabo
Wounds that are more likely to get tetanus infection are burns, fractures, deep wounds or wounds that have soil, dust, horse manure or wood splinters in them.
Rane, ki se še posebno rade okužijo s tetanusom, so opekline, zlomi, globoke rane ali rane onesnažene z zemljo,
Bordetella pertussis antigens Pertussis toxoid (PT)1
antigeni Bordetella pertussis toksoid Bordetella pertussis (PT)1
Talk to your doctor or pharmacist before your child is given Infanrix hexa:
se posvetujte z zdravnikom ali s farmacevtom, preden bo vaš otrok cepljen s cepivom Infanrix hexa.
The physician should be aware that the rate of febrile reactions is higher when Infanrix hexa is coadministered with a pneumococcal conjugate vaccine (PCV7, PCV10, PCV13), or with a measlesmumps-rubella-varicella (MMRV) vaccine, compared to that occurring following the administration of Infanrix hexa alone.
Zdravnik se mora zavedati, da je delež febrilnih reakcij večji, če je cepivo Infanrix hexa uporabljeno sočasno s konjugiranim pnevmokoknim cepivom (PCV7, PCV10, PCV13) ali s cepivom MMRV
Filamentous Haemagglutinin (FHA)1
25 mikrogramov filamentozni hemaglutinin (FHA)1
How the vaccine is given
Kako bo vaš otrok prejel cepivo
Rash, Angioedema2
Redki izpuščaj, angioedem2
The coughing often has a “whooping” sound.
Kašelj ima značilen zvok, ki zveni kot oslovski glas.
Analysis of postmarketing reporting rates suggests a potential increased risk of convulsions (with or without fever) and HHE when comparing groups which reported use of Infanrix hexa with Prevenar 13 to those which reported use of Infanrix hexa alone.
Analiza pogostnosti poročanja v obdobju trženja nakazuje potencialno povečano tveganje za konvulzije (z ali brez vročine) in hipotonično-hiporesponzivno epizodo pri skupini, ki je prejela cepivo Infanrix hexa in cepivo Prevenar 13 v primerjavi s skupino, ki je prejela le cepivo Infanrix hexa.
Data from clinical studies show similar incidences of fever when Infanrix hexa is co-administered with other pneumococcal saccharide conjugated vaccine.
Podatki iz kliničnih študij kažejo podobno pojavnost zvišane telesne temperature, če je cepivo Infanrix hexa uporabljeno skupaj s konjugiranim pnevomokoknim polisaharidnim cepivom.
Results of long term follow-up in Sweden demonstrate that acellular pertussis vaccines are efficacious in infants when administered according to the 3 and 5 months primary vaccination schedule, with a booster dose administered at approximately 12 months.
Pri dolgotrajnem spremljanju cepiv na Švedskem se je izkazalo, da so brezcelična cepiva proti oslovskemu kašlju učinkovita, če so bili otroci osnovno cepljeni po shemi 3. in 5. mesec starosti ter so prejeli obnovitveni odmerek pri približno 12 mesecih starosti.
Fever of greater than 39.5°C was reported in 18% of children receiving Infanrix hexa with MMRV vaccine, as compared to 3.3% of children receiving Infanrix hexa alone and 19.3% of children receiving MMRV alone (see sections 4.4 and 4.5).
Zvišano telesno temperaturo nad 39,5 °C so zabeležili pri 18 % otrok, ki so dobili cepivo Infanrix hexa skupaj s cepivom MMRV, pri 3,3 % otrok, ki so dobili cepivo Infanrix hexa samo, in pri 19,3 % otrok, ki so dobili cepivo MMRV samo (glejte poglavji 4.4 in 4.5).
Infanrix hexa can be given concomitantly with pneumococcal conjugate vaccines (PCV7, PCV10 and PCV13), meningococcal serogroup C conjugate vaccine (CRM197 and TT conjugates), meningococcal serogroups A, C, W-135 and Y conjugate vaccine (TT conjugate), meningococcal serogroup B vaccine (MenB), oral rotavirus vaccine and measles-mumps-rubella-varicella (MMRV) vaccine.
PCV10 in PCV13), konjugiranim cepivom proti meningokokom serološke skupine C (konjugati CRM 197 in TT), konjugiranim cepivom proti meningokokom seroloških skupin A, C, W-135 in Y (konjugat TT), cepivom proti meningokokom seroskupine B (MenB) peroralnim cepivom proti rotavirusom in cepivom MMRV (cepivo proti ošpicam-mumpsu-rdečkam-noricam).
Infanrix hexa is indicated for primary and booster vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b.
Cepivo Infanrix hexa je indicirano za osnovno in obnovitveno cepljenje dojenčkov in otrok proti davici, tetanusu, oslovskemu kašlju, hepatitisu B, otroški ohromelosti in boleznim, ki jih povzroča Haemophilus influenzae tipa b.
Upon storage, a clear liquid and white deposit may be observed in the pre-filled syringe containing the DTPa-HBV-IPV suspension.
Med shranjevanjem se lahko v napolnjeni injekcijski brizgi, ki vsebuje suspenzijo DTPa-HBV-IPV, pojavi bistra tekočina in bela usedlina.
In a clinical study in which some of the vaccinees received a booster dose of Infanrix hexa concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine, fever ≥ 38.0°C was reported in 76.6% of children receiving MMRV vaccine and Infanrix hexa at the same time, as compared to 48% of children receiving Infanrix hexa alone and 74.7% of children receiving MMRV vaccine alone.
V klinični študiji, v kateri so nekateri cepljeni otroci dobili obnovitveni odmerek cepiva Infanrix hexa sočasno s cepivom MMRV (cepivo proti ošpicam-mumpsu-rdečkam-noricam), so zvišano telesno temperaturo ≥ 38,0 °C zabeležili pri 76,6 % otrok, ki so hkrati prejeli cepivi MMRV in Infanrix hexa;
months N= 196 (2 studies)
mesece N = 196 (2 študiji)
This can cause muscle stiffness, painful muscle spasms, fits and even death.
Bakterije sproščajo strup, ki lahko povzroči otrplost mišic, boleče krče mišic, krče in celo smrt.
Infanrix hexa should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Otrokom s trombocitopenijo ali motnjami strjevanja krvi cepivo Infanrix hexa dajemo previdno, ker se pri njih po intramuskularni aplikaciji lahko pojavi krvavitev.
This can cause death by suffocation.
Lahko povzroči tudi oteklost grla, kar lahko povzroči smrt z zadušitvijo.
N = number of subjects * in a subgroup of infants not administered hepatitis B vaccine at birth, 77.7% of subjects had anti-HBs titres ≥ 10 mIU/ml ** Post booster, 98.4% of subjects had anti-PRP concentration ≥ 1 µg/ml indicative of long-term protection † cut-off accepted as indicative of protection
N = število preiskovancev * V podskupini otrok, ki ob rojstvu niso dobili cepiva proti hepatitisu B, jih je 77,7 % imelo titre anti-HBs ≥ 10 mi.e./ml.
• Infanrix hexa is available in packs of 1 and 10 with or without needles, and a multipack of 5 packs,
• Cepivo Infanrix hexa je na voljo v pakiranjih po 1 in 10 napolnjenih injekcijskih brizg s priloženimi injekcijskimi iglami ali brez njih in pakiranje, ki vsebuje 5 posameznih pakiranj z 10 vialami in 10 napolnjenimi injekcijskimi brizgami brez igel.
Poliovirus (inactivated) type 1 (Mahoney strain)4
10 mikrogramov poliovirus (inaktivirani) tip 1 (sev Mahoney) 4
1 dose (0.5 ml)
(0,5 ml).
Store in the original package, in order to protect from light.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Pack sizes of 1 and 10 with or without needles and a multipack of 5 packs, each containing 10 vials and 10 pre-filled syringes, without needles.
Pakiranja po 1 in 10 napolnjenih injekcijskih brizg s priloženimi injekcijskimi iglami ali brez njih in pakiranje, ki vsebuje 5 posameznih pakiranj z 10 vialami in 10 napolnjenimi injekcijskimi brizgami brez igel.
In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria-tetanus, hepatitis B, polio and Hib vaccines.
V takšnih primerih moramo cepljenje proti oslovskemu kašlju opustiti, cepljenje pa nadaljevati s cepivi proti davici, tetanusu, hepatitisu B, otroški ohromelosti in Hib.
Uncommon (these may occur with up to 1 in 100 doses of the vaccine): upper respiratory tract infection, feeling sleepy, cough, large swelling at the injected limb.
Občasni (pojavijo se lahko pri največ 1 od 100 odmerkov cepiva): okužbe zgornjih dihalnih poti, občutek zaspanosti, kašelj, močna oteklost uda, v katerega je bilo injicirano cepivo.
Store in a refrigerator (2°C - 8°C).
6.4 Posebna navodila za shranjevanje Shranjujte v hladilniku (2 ºC - 8 ºC).
QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid1
KAKOVOSTNA IN KOLIČINSKA SESTAVA Po rekonstituciji en odmerek cepiva (0,5 ml) vsebuje:
This can cause nerve damage, heart problems, and even death.
Bakterije sproščajo tudi strup, ki lahko poškoduje živce, povzroči težave s srcem in celo smrt.
2produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3adsorbed on aluminium phosphate (AlPO4)
2pridobljen s tehnologijo rekombinantne DNA na celični kulturi Saccharomyces cerevisiae
• There should be an interval of at least 1 month between primary doses.
• Med posameznimi odmerki v primarnem cepljenju mora miniti vsaj 1 mesec.
However the stability has been demonstrated for 8 hours at 21°C after reconstitution.
Po rekonstituciji: priporoča se takojšnja uporaba, čeprav so na voljo podatki o stabilnosti cepiva 8 ur pri 21 °C po rekonstituciji.
Bordetella pertussis antigens Pertussis toxoid1
antigeni Bordetella pertussis toksoid Bordetellae pertussis1
The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Lahko se zgodi, da pri bolnikih, ki prejemajo imunosupresivno terapijo, po cepljenju ne dosežete ustreznega imunskega odziva.
However, data indicate that protection against pertussis may be waning at 7-8 years of age with this 3-5-12 month's schedule.
Vendar pa podatki kažejo tudi, da pri cepljenju po shemi (3-5-12 mesec) zaščita proti oslovskemu kašlju v starosti od 7 do 8 let lahko oslabi,
As for any vaccination, the risk-benefit of immunising with Infanrix hexa or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.
Pri dojenčku ali otroku, pri katerem se je pojavilo novo hujše nevrološko obolenje ali pa je prišlo do njegovega poslabšanja, je, tako kot pri vsakem cepljenju, treba skrbno presoditi o koristih in tveganjih, povezanih s cepljenjem ali z odložitvijo cepljenja s cepivom Infanrix hexa.
This suggests that a second booster dose of pertussis vaccine is warranted in children aged 5-7 years who have previously been vaccinated following this particular schedule.
kar kaže, da je pri otrocih, ki so bili cepljeni po tej shemi, v starosti od 5 do 7 let upravičeno cepljenje še z drugim obnovitvenim odmerkom cepiva.
Ask your pharmacist how to throw away medicines your child no longer uses.
O načinu odstranjevanja cepiva, ki ga ne potrebujete več, se posvetujte s farmacevtom.
Post-dose 3
Po 3. odmerku
Multipack comprising 5 packs, each containing 10 vials and 10 pre-filled syringes without needles 50 x 1 dose (0.5 ml)
V pakiranju je 5 posameznih pakiranj z 10 vialami in 10 napolnjenimi injekcijskimi brizgami brez igel 50 x 1 odmerek (0,5 ml)
How to store Infanrix hexa
Kako uporabljati cepivo Infanrix hexa
2-dose
2 odmerka
Antibody (cut-off)
Protitelo (mejna vrednost)
Hepatitis B surface antigen2,3
8 mikrogramov površinski antigen virusa hepatitisa B2,3
(polyribosylribitol phosphate) 2 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
(poliribozilribitol-fosfat)2 vezan na tetanusni toksoid kot nosilni protein približno 25 mikrogramov
Clinical data indicate that Infanrix hexa can be given to preterm infants, however, as expected in this population, a lower immune response has been observed for some antigens (see section 4.8 and section
Vendar je bil pri tej populaciji, v skladu s pričakovanji, opažen manjši imunski odziv za nekatere antigene (glejte poglavji 4.8 in 5.1).
• rashes that may be itchy or blistering
• izpuščaj, ki lahko srbi ali ga spremlja pojav mehurjev,
(polyribosylribitol phosphate)3 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
(poliribozilribitol-fosfat)3 vezan na tetanusni toksoid kot nosilni protein približno 25 mikrogramov
Percentage of subjects with antibody titres indicative of seroprotection / seropositivity one month after 2-dose primary and booster vaccination with Infanrix hexa
Odstotek preiskovancev, pri katerih so titri protiteles kazali na serološko zaščito/seropozitivnost en mesec po primarnem cepljenju z 2 odmerkoma in obnovitvenem odmerku cepiva Infanrix hexa
(polyribosylribitol phosphate, PRP) 3 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
(poliribozilribitol-fosfat, PRP)3 vezan na tetanusni toksoid kot nosilni protein približno 25 mikrogramov
If your child gets any side effects, talk to your doctor or pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Uncommon Upper respiratory tract infection
Infekcijske in parazitske bolezni Občasni okužbe zgornjih dihalnih poti
Efficacy study (NIH sponsored)
(sponzorirana s strani NIH)
Diarrhoea, vomiting
Pogosti driska, bruhanje
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DTPa HBV IPV for Infanrix hexa
IME ZDRAVILA IN POT(I) UPORABE DTPa HBV IPV za Infanrix hexa suspenzija za suspenzijo za injiciranje i.m.