natgillin/translations-raw huggingface dataset:
After control of the disease the vaccine can be given.
Cepivo lahko prejme, ko je bolezen pod nadzorom;
In comparative clinical studies, similar rates of symptoms were observed in preterm and full-term infants (refer to section 4.4 for information on apnoea).
V primerjalnih kliničnih študijah so pri nedonošenčkih in donošenih otrocih opažali podobne deleže simptomov (glejte poglavje 4.4 za informacije o apneji).
The following side effects may happen with this vaccine:
Pri tem cepivu se lahko pojavijo naslednji neželeni učinki:
• Do not throw away any medicines via wastewater or household waste.
• Cepiva ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
• The booster dose should be given at least 6 months after the last priming dose and preferably before 18 months of age.
• Obnovitveni odmerek je treba dati vsaj 6 mesecev po zadnjem odmerku osnovnega cepljenja in po možnosti pred 18. mesecem starosti.
• Whooping cough (Pertussis): a highly infectious illness that affects the airways.
• Oslovski kašelj (pertusis): je zelo nalezljiva bolezen, ki prizadene dihalne poti.
As with other vaccines it may be expected that in patients receiving immunosuppressive therapy, an adequate response may not be achieved.
Kot pri drugih cepivih lahko tudi pri tem pričakujete, da pri bolnikih, ki prejemajo imunosupresivno terapijo, ne bo dosežen zadosten odziv na cepljenje.
Persistence of the immune response
Ohranjanje imunskega odziva
EU/1/00/152/001 - 1 vial and 1 pre-filled syringe without needle EU/1/00/152/002 - 10 vials and 10 pre-filled syringes without needles EU/1/00/152/005 - 1 vial and 1 pre-filled syringe with 2 needles EU/1/00/152/006 - 10 vials and 10 pre-filled syringes with 20 needles
EU/1/00/152/001- 1 viala in 1 napolnjena injekcijska brizga brez igle EU/1/00/152/002 - 10 vial in 10 napolnjenih injekcijskih brizg brez igel EU/1/00/152/005 - 1 viala in 1 napolnjena injekcijska brizga z 2 iglama EU/1/00/152/006 - 10 vial in 10 napolnjenih injekcijskih brizg z 20 iglami
Bronchitis, apnoea2 [see section 4.4 for apnoea in very preterm infants (≤ 28 weeks of gestation)]
Redki bronhitis, apneja2 [glejte poglavje 4.4 glede apneje pri zelo nedonošenih (rojenih pred ali v 28. tednu nosečnosti)]
Post-dose 4 (Booster vaccination during the second year of life following a 3-dose primary course)
Po 4. odmerku (Obnovitveno cepljenje v drugem letu življenja, po opravljenem primarnem cepljenju s 3 odmerki)
The pre-filled syringe should be well shaken in order to obtain a homogeneous turbid white suspension.
Napolnjeno brizgo je treba dobro pretresti, da nastane homogena, motna bela suspenzija.
What you need to know before your child receives Infanrix hexa
Kaj morate vedeti, preden bo vaš otrok prejel cepivo Infanrix hexa
Prophylactic administration of antipyretics before or immediately after vaccine administration can reduce the incidence and intensity of post-vaccination febrile reactions.
Profilaktična uporaba antipiretikov pred dajanjem cepiva ali tik po njem lahko zmanjša incidenco in izrazitost febrilnih reakcij po cepljenju.
• The booster dose should be given at least 6 months after the last priming dose and preferably between 11 and 13 months of age.
• Obnovitveni odmerek je treba dati vsaj 6 mesecev po zadnjem odmerku osnovnega cepljenja in po možnosti med 11. in 13. mesecem starosti.
Infanrix hexa contains neomycin and polymyxin This vaccine contains neomycin and polymyxin (antibiotics).
Cepivo Infanrix hexa vsebuje neomicin in polimiksin To cepivo vsebuje neomicin ali polimiksin (antibiotika).
If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used.
Če mora otrok prejeti drugi odmerek cepiva proti hepatitisu B pred to starostjo, moramo uporabiti monovalentno cepivo proti hepatitisu B.
including induration, local swelling at the injection site (> 50 mm)1
lokalna oteklina na mestu injiciranja (> 50 mm)1
The persistence of the immune response to a 3-dose primary (at 2-3-4, 3-4-5 or 2-4-6 months of age) and booster (in the second year of life) schedule with Infanrix hexa was evaluated in children 4-8 years of age.
Vztrajanje imunskega odziva po primarnem cepljenju s 3 odmerki (pri 2-3-4, 3-4-5 ali 2-4-6 mesecih starosti) in obnovitvenem odmerku (v drugem letu starosti) s cepivom Infanrix hexa je bilo ocenjeno pri otrocih v starosti do 4 do 8 let.
Polio can make the muscles unable to move (paralysis).
Zaradi otroške paralize lahko mišice postanejo negibne (paraliza).
• if your child has had problems of the nervous system within 7 days after previous vaccination with a vaccine against whooping cough
• če je kdaj imel težave z živčevjem v prvih 7 dneh po cepljenju s cepivom proti oslovskemu kašlju;
What Infanrix hexa is and what it is used for
Kaj je cepivo Infanrix hexa in za kaj ga uporabljamo
• if after previously having Infanrix hexa or another vaccine against whooping cough, your child had any problems, especially: - a high temperature (over 40°C) within 48 hours of vaccination - a collapse or “shock-like” state within 48 hours of vaccination - persistent crying lasting 3 hours or more within 48 hours of vaccination - fits with or without a high temperature within 3 days of vaccination
• če je po predhodnem cepljenju s cepivom Infanrix hexa ali drugim cepivom proti oslovskemu kašlju vaš otrok imel kakršnekoli težave, še posebej: - visoko telesno temperaturo (nad 40 ºC) v 48 urah po cepljenju; - kolaps ali »šoku podobno« stanje v 48 urah po cepljenju;
The incidence and severity of fever following co-administration of the two vaccines in the primary series was lower than that observed after the booster dose.
Incidenca in resnost zvišane telesne temperature po sočasni uporabi obeh cepiv je bila med osnovnim cepljenjem manjša kot po obnovitvenem odmerku.
The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of age) may only be used if a dose of hepatitis B vaccine has been given at birth.
Razširjeno shemo cepljenja (v 6., 10., 14. tednu starosti) lahko uporabite le v primeru, če je bil otrok cepljen proti hepatitisu B že ob rojstvu.
• Infanrix hexa will be given as an injection into a muscle.
• Cepivo Infanrix hexa bo zdravnik dal v obliki injekcije v mišico.
• if your child has a bleeding problem or bruises easily
• če ima vaš otrok težave s krvavitvami ali hitrim nastankom modric;
Where a dose of hepatitis B vaccine is given at birth, Infanrix hexa can be used as a replacement for supplementary doses of hepatitis B vaccine from the age of six weeks.
Kadar otrok prejme prvi odmerek cepiva proti hepatitisu B ob rojstvu, lahko uporabimo cepivo Infanrix hexa kot nadomestilo za dodatne odmerke cepiva proti hepatitisu B od starosti šestih tednov dalje.
• Experience with hepatitis B vaccine:
• Izkušnje s cepivom proti hepatitisu B:
The muscle spasms can be strong enough to cause bone fractures of the spine.
Krči mišic so lahko tako siloviti, da povzročijo zlom hrbtenice.
Infanrix hexa should not be given:
Vaš otrok cepiva Infanrix hexa ne sme prejeti:
This rises to 88% in case of concomitant use of pneumococcal vaccine containing tetanus toxoid as carrier and to 98% when Infanrix hexa is co-administered with a TT conjugated meningococcal vaccine (see section 4.5).
Ta delež se zviša na 88 % v primeru sočasne uporabe pnevmokoknega cepiva, ki kot nosilec vsebuje tetanusni toksoid, in na 98 %, če je cepivo Infanrix hexa uporabljeno sočasno s TT konjugiranim meningokoknim cepivom (glejte poglavje 4.5).
Very common Fever ≥ 38°C, local swelling at the injection site (≤ 50 mm), fatigue, pain,
Zelo pogosti zvišana telesna temperatura ≥ 38 °C, lokalna oteklina na mestu injiciranja (≤ 50 mm), utrujenost, bolečine, pordelost
A booster dose must be given.
Uporabiti je treba obnovitveni odmerek.
Since the Hib capsular polysaccharide antigen is excreted in the urine, a positive urine test can be observed within 1-2 weeks following vaccination.
Moteč vpliv na laboratorijske preiskave Kapsularni polisaharidni antigen Hib se izloča v urin, zato se lahko v 1 do 2 tednih po cepljenju pojavi pozitiven izvid urinskega testa.
• Polio: a viral infection.
• Otroška paraliza: je virusna okužba.
The airways become swollen causing serious breathing problems and sometimes suffocation.
Dihalne poti otečejo, kar povzroči resne dihalne težave in občasno dušenje.
What Infanrix hexa is and what it is used for What you need to know before your child receives Infanrix hexa How Infanrix hexa is given
Kaj je cepivo Infanrix hexa in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok prejel cepivo Infanrix hexa Kako uporabljati cepivo Infanrix hexa
The vaccine was assessed in 2-dose and 3-dose priming schedules, including the schedule for the Expanded Program on Immunisation, and as a booster dose.
Cepivo so ocenili v shemi osnovnega cepljenja z 2 in 3 odmerki, vključno z Razširjeno shemo cepljenja, in kot obnovitveni odmerek.
These children had received Infanrix hexa as primary and booster vaccination in infancy, and when an additional dose of monovalent HBV vaccine was administered, protective immunity was observed in at least 93% of subjects.
Ti otroci so dobili cepivo Infanrix hexa kot primarno in obnovitveno cepljenje v obdobju dojenčka; če je bil uporabljen dodaten odmerek monovalentnega cepiva proti HBV, je bila zaščitna imunost opažena pri vsaj 93 %
Experience with hepatitis B vaccine
Izkušnje s cepivom proti hepatitisu B
The use of prophylactic antipyretic medicinal products is recommended for children with seizure disorders or with a prior history of febrile seizures.
Profilaktična uporaba antipiretičnih zdravil je priporočljiva pri otrocih s krči ali z anamnezo vročinskih krčev.
When Infanrix hexa was co-administered with MenB and pneumococcal conjugate vaccines, inconsistent results were seen across studies for responses to inactivated poliovirus type 2, pneumococcal conjugate serotype 6B antigen and to the pertussis pertactin antigen but these data do not suggest clinically significant interference.
Ko so cepivo Infanrix hexa uporabili sočasno s cepivom proti MenB in pnevmokoknimi konjugiranimi cepivi, so v študijah opazili nekonsistentne rezultate za odziv na inaktivirani poliovirus tipa 2, antigen pnevmokoknega konjugiranega serotipa 6B in na antigen oslovskega kašlja pertaktin, vendar ti podatki ne kažejo na klinično pomembno medsebojno delovanje.
Allergic reactions (including pruritus)2
(vključno z urtikarijo)2, alergijske reakcije (vključno s srbenjem)2
As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section
Kot velja za vsa cepiva, zaščitnega imunskega odziva ni vedno mogoče izzvati pri vseh cepljenih osebah (glejte poglavje 5.1).
Tetanus toxoid1
tetanusni toksoid1
3-5-11 months of age N=532 (3 studies)
3-5-11 mesecev starosti N = 532 (3 študije)
The response to the booster dose in terms of fold increases in antibody concentrations (15- to 235-fold), indicate that preterm infants were adequately primed for all the antigens of Infanrix hexa.
Odziv na obnovitveni odmerek glede na faktor povečanja koncentracije protiteles (od 15-kratno do 235-kratno povečanje) kaže, da so bili nedonošenčki ustrezno primarno cepljeni za vse antigene v cepivu Infanrix hexa.
Data have shown no clinically relevant interference in the antibody response to each of the individual antigens, although inconsistent antibody response to poliovirus type 2 in co-administration with Synflorix was observed (seroprotection ranging from 78% to 100%) and the immune response rates to the PRP (Hib) antigen of Infanrix hexa after 2 doses given at 2 and 4 months of age were higher if coadministered with a tetanus toxoid conjugate pneumococcal or meningococcal vaccine (see section 5.1).
Podatki ne kažejo klinično pomembnega medsebojnega delovanja pri tvorbi protiteles proti vsakemu posameznemu antigenu, so pa po sočasni uporabi s cepivom Synflorix opažali nekonsistenten odziv protiteles na poliovirus tipa 2 (serološka zaščita je segala od 78 do 100 %) ter večji odziv imunskega odziva na PRP (Hib) antigen cepiva Infanrix hexa po 2 odmerkih, uporabljenih pri 2. in 4. mesecih starosti, če je bilo cepivo uporabljeno skupaj z na tetanusni toksoid vezanim pnevmokoknim ali meningokoknim cepivom (glejte poglavje 5.1).
• if your child should become unresponsive or experience seizures (fits) after the vaccination, please contact your doctor immediately.
• če vaš otrok postane neodziven ali dobi krče po cepljenju, takoj kontaktirajte vašega zdravnika.
In extremely rare cases, allergic reactions mimicking serum sickness, paralysis, neuropathy, neuritis, hypotension, vasculitis, lichen planus, erythema multiforme, arthritis, muscular weakness, GuillainBarré syndrome, encephalopathy, encephalitis and meningitis have been reported.
V izjemno redkih primerih so poročali o alergijski reakciji podobni serumski bolezni, paralizi, nevropatiji, nevritisu, hipotenziji, vaskulitisu, lichen planusu, multiformnem eritemu, artritisu, mišični šibkosti, Guillain-Barréjevem sindromu, encefalopatiji, encefalitisu in meningitisu.
40 D-antigen unit type 2 (MEF-1 strain)4
40 D-antigenskih enot tip 2 (sev MEF-1) 4
Additionally, following a 2-dose primary and booster schedule, seroprotective antibody concentrations against hepatitis B persisted in ≥ 48% of subjects 11-12 years of age.
Poleg tega je po shemi primarnega cepljenja z 2 odmerkoma in obnovitvenim odmerkom serozaščitna koncentracija protiteles proti hepatitisu B trajala pri ≥ 48 % preiskovancev v starosti od 11 do 12 let.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/152/021 - pack of 50 (5 X 10) without needles
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/152/021 - pakiranje po 50 (5 x 10) brez igel
One month after the booster dose at least 98.4% of subjects had seroprotective or seropositive antibody levels against each of the antigens except against PT (at least 96.8%) and hepatitis B (at least 88.7%).
En mesec po obnovitvenem odmerku je imelo vsaj 98,4 % preiskovancev serološko zaščitno ali seropozitivno koncentracijo protiteles proti vsakemu od antigenov, razen proti PT (vsaj 96,8 %) in hepatitisu B (vsaj 88,7 %).
Convulsions (with or without fever)
Zelo redki konvulzije (z zvišano telesno temperaturo ali brez nje)
The vaccine suspension should be inspected visually before and after reconstitution for any foreign particulate matter and/or abnormal physical appearance.
Preveriti morate videz suspenzije cepiva, pred in po rekonstituciji, glede morebitne prisotnosti tujih delcev in/ali neobičajnega fizikalnega videza cepiva.
The mixture should be well shaken until the powder is completely dissolved prior to administration.
Mešanico dobro pretresemo, da se prašek, pred dajanjem, popolnoma raztopi.
• Instructions for use of pre-filled syringe if supplied with a PRTC luer lock adaptor
• Navodila za uporabo napolnjene injekcijske brizge opremljene z nastavkom luer lock s PRTC
Rare (these may occur with up to 1 in 1,000 doses of the vaccine): bronchitis, rash, swollen glands in the neck, armpit or groin (lymphadenopathy), bleeding or bruising more easily than normal (thrombocytopenia), in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination, temporarily stopping breathing (apnoea), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), swelling of the whole injected limb, blisters.
Redki (pojavijo se lahko pri največ 1 od 1.000 odmerkov cepiva): bronhitis, izpuščaj, oteklost bezgavk na vratu, v pazduhah ali dimljah (limfadenopatija), hitrejše krvavitve ali pojav modric od običajnega (trombocitopenija), pri zelo prezgodaj rojenih dojenčkih (28. teden nosečnosti ali prej) se lahko 2 do 3 dni po cepljenju pojavijo daljši presledki med dihi, kot je običajno, začasna prekinitev dihanja (apneja), otekanje obraza, ustnic, ust, jezika ali žrela, ki lahko povzroči težave s požiranjem ali dihanjem (angioedem), oteklost celotnega uda, v katerega je bilo injicirano cepivo, mehurčki.
• Make sure your child finishes the complete vaccination course.
• Preverite, ali je vaš otrok v okviru osnovnega cepljenja prejel vse odmerke.
Infanrix hexa can be considered for the booster if the antigen composition is in accordance with the official recommendations.
Cepivo Infanrix hexa je mogoče uporabiti za obnovitveno cepljenje, če je njegova antigenska sestava v skladu z uradnimi priporočili.
One month after primary vaccination at least 98.7% of subjects were seroprotected against diphtheria, tetanus and poliovirus types 1 and 2; at least 90.9% had seroprotective antibody levels against the hepatitis B, PRP and poliovirus type 3 antigens; and all subjects were seropositive for antibodies against FHA and PRN while 94.9% were seropositive for anti-PT antibodies.
En mesec po primarnem cepljenju je bilo vsaj 98,7 % preiskovancev serološko zaščitenih pred davico, tetanusom in poliovirusom tipov 1 in 2; vsaj 90,9 % jih je imelo serološko zaščitno koncentracijo protiteles proti antigenom hepatitisa B, PRP in poliovirusu tipa 3; in vsi preiskovanci so bili seropozitivni za protitelesa proti FHA in PRN, medtem kot je bilo 94,9 % seropozitivnih za protitelesa proti PT.
0.5 ml of suspension in a pre-filled syringe (type I glass) with plunger stopper (butyl).
0,5 ml suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z zamaškom iz butilne gume.
The clinical protection of the pertussis component of Infanrix (DTPa), against WHO-defined typical pertussis (≥ 21 days of paroxysmal cough) was demonstrated after 3-dose primary immunisation in the studies tabulated below:
Klinična zaščita s sestavino pertusis cepiva Infanrix (DTPa) proti značilnemu oslovskemu kašlju v skladu z definicijo Svetovne zdravstvene organizacije (napadi kašlja, ki trajajo ≥ 21 dni) je bila dokazana po primarni imunizaciji s 3 odmerki v študijah, prikazanih v spodnji preglednici:
Name and address of the manufacturers of the biological active substances
Ime in naslov izdelovalcev biološke zdravilne učinkovine (učinkovin)
The pre-filled syringe can be supplied with either a ceramic coated treatment (CCT) of the luer tip or with a plastic rigid tip cap (PRTC) luer lock adaptor.
Napolnjena injekcijska brizga je lahko opremljena bodisi s keramičnim kritjem (CCT, ceramic coated treatment) konice luer bodisi z nastavkom luer lock s plastičnim togim pokrovčkom konice (PRTC, plastic rigid tip cap).
Results of ongoing routine national surveillance in Italy demonstrate that Infanrix hexa is effective in controlling Hib disease in infants when the vaccine is administered according to the 3 and 5 months primary vaccination schedule, with a booster dose administered at approximately 11 months.
Rezultati potekajočega rutinskega nacionalnega spremljanja v Italiji kažejo, da je cepivo Infanrix hexa učinkovito pri obvladovanju bolezni Hib pri dojenčkih, če je cepivo uporabljeno po 3- in 5-mesečnem razporedu primarnega cepljenja in z obnovitvenim odmerkom po približno 11 mesecih.
Bleeding or bruising more easily than normal (thrombocytopenia) has been reported with hepatitis B vaccines.
Krvavitve ali hitrejši pojav modric od običajnega (trombocitopenija) so bili poročani v povezavi s cepivom proti hepatitisu B.
Fever >39.5°C, injection site reactions,
Pogosti zvišana telesna temperatura > 39,5 °C, reakcije na mestu injiciranja, vključno z zatrdlino,
According to different studies, immune response to the PRP antigen of Infanrix hexa after 2 doses given at 2 and 4 months of age will vary if co-administered with a tetanus toxoid conjugate vaccine.
Različne študije kažejo, da se imunski odziv na antigen PRP v cepivu Infanrix hexa po 2 odmerkih, uporabljenih 2. in 4. mesec, razlikuje, če je cepivo uporabljeno sočasno s konjugiranim tetanusnim toksoidnim cepivom.
• Hepatitis B: is caused by the hepatitis B virus.
• Hepatitis B: povzroča ga virus hepatitisa B, ki povzroči oteklino jeter (vnetje).
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Kot pri vseh drugih cepivih, ki jih injiciramo, morate imeti na voljo ustrezno zdravljenje in nadzor v redkih primerih anafilaktične reakcije, ki lahko sledi cepljenju.
Locally established immunoprophylactic measures against hepatitis B should be maintained.
Treba je upoštevati lokalno uveljavljena priporočila imunoprofilakse proti hepatitisu B. Pediatrična populacija
Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.
Znaki preobčutljivostne reakcije lahko vključujejo srbečo kožo, kožni izpuščaj, zasoplost in zatekanje obraza ali jezika;
Italy 2,4,6 months 84% In a follow-up of the same cohort, the efficacy was confirmed up to 60 months after completion of primary vaccination without administration of a booster dose of pertussis.
84 % Pri spremljanju iste kohorte je bila učinkovitost potrjena do 60. meseca po popolnem osnovnem cepljenju brez dajanja obnovitvenega odmerka proti oslovskemu kašlju.
Serological correlates of protection have been established for diphtheria, tetanus, polio, Hepatitis B and Hib.
Serološki korelati zaščite so bili ugotovljeni za davico, tetanus, polio, hepatitis B in Hib.
Do not administer the vaccine intravascularly or intradermally.
Cepiva ne dajemo intravaskularno ali intradermalno.
Over a seven year follow-up period, the effectiveness of the Hib components of two hexavalent vaccines, of which one was Infanrix hexa, was 89.6% for a full primary series and 100% for a full primary series plus booster dose (irrespective of the Hib vaccine used for priming).
Po sedmih letih spremljanja je bila učinkovitost komponent proti Hib dveh šestvalentnih cepiv, od katerih je bilo eno cepivo Infanrix hexa, po popolnem osnovnem cepljenju 89,6 %, po popolnem osnovnem cepljenju in cepljenju z obnovitvenim odmerkom pa 100 % (neodvisno od izbire cepiva Hib za osnovno cepljenje).
The virus is found in body fluids such as in the vagina, blood, semen or spit (saliva) of infected people.
Pri okuženih ljudeh se virus nahaja v telesnih tekočinah, kot so kri, sperma ali izpljunek (slina) ter v nožnici.
As with other vaccines, administration of Infanrix hexa should be postponed in subjects suffering from acute severe febrile illness.
Kot pri cepljenju z drugimi cepivi, moramo cepljenje s cepivom Infanrix hexa odložiti pri otrocih, ki prebolevajo hudo akutno vročinsko bolezen.
Hepatitis B surface antigen (HBs)2,3
8 mikrogramov površinski antigen virusa hepatitisa B (HBs)2,3
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 odmerek
(≥1/10,000 to <1/1,000)
(≥ 1/10.000 do < 1/1.000)
At least 25.4% (anti-PT), 97.5% (anti-FHA) and 87.0% (anti-PRN) of children were seropositive against the pertussis components.
Proti komponentam oslovskega kašlja je bilo seropozitivnih vsaj 25,4 % (anti-PT), 97,5 % (anti-FHA) in 87,0 % (anti-PRN) otrok.
DTPa-HBV-IPV suspension: sodium chloride (NaCl), medium 199 containing principally amino acids, mineral salts, vitamins and water for injections
DTPa-HBV-IPV suspenzija: natrijev klorid (NaCl), medij 199, ki vsebuje predvsem aminokisline, mineralne soli, vitamine in voda za injekcije
months N= 1693 (6 studies)
mesecev N = 1693 (6 študij)
As Infanrix hexa is not intended for use in adults, adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
4.6 Plodnost, nosečnost in dojenje Ker cepivo Infanrix hexa ni namenjeno uporabi pri odraslih, ni podatkov o uporabi med nosečnostjo in dojenjem, prav tako ni na voljo ustreznih študij o vplivu na razmnoževanje pri živalih.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety, specific toxicity, repeated dose toxicity and compatibility of ingredients.
Predklinični podatki na osnovi običajnih študij varnosti, specifične toksičnosti, toksičnosti pri ponavljajočih se odmerkih in kompatibilnosti sestavin ne kažejo posebnega tveganja za človeka.
Read the package leaflet before use Intramuscular use Shake well before use
Pred uporabo preberite priloženo navodilo za intramuskularno uporabo Pred uporabo dobro pretresite