natgillin/translations-raw huggingface dataset:
For instructions on handling see section 6.6. 
Za navodila zdravila pred dajanjem glejte poglavje 6.6.
• Hexacima should not be mixed with other medicinal products. 
• Cepiva Hexacima ne smete mešati z drugimi zdravili.
In the throat, the infection causes pain and swelling which can lead to suffocation. 
V grlu okužba povzroči bolečino in otekanje, ki lahko privede do zadušitve.
• Haemophilus influenzae type b infections (often just called Hib) are serious bacterial infections and can cause meningitis (inflammation of the outer covering of the brain), which can lead to brain damage, deafness, epilepsy, or partial blindness. 
• Okužbe s Haemophilusom influenzae tipa b (pogosto imenovan Hib) so hude bakterijske okužbe in lahko povzročajo meningitis (vnetje zunanje možganske ovojnice), kar lahko privede do poškodb možganov, gluhosti, epilepsije ali delne slepote.
If Guillain-Barré syndrome or brachial neuritis has occurred following receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks, such as whether or not the primary vaccination has been completed. 
Če se po prejemu predhodnega cepiva, ki vsebuje tetanusni toksoid, razvije Guillain-Barréjev sindrom ali brahialni nevritis, je treba odločitev o nadaljevanju cepljenja s cepivi, ki vsebujejo tetanusni toksoid, skrbno pretehtati glede na morebitne koristi in tveganja, kot na primer, ali je bila osnovna shema cepljenja zaključena.
• Tetanus (often called lock jaw) is usually caused by the tetanus bacteria entering a deep wound. 
• Tetanus (pogosto imenovan mrtvični krč) običajno povzročajo bakterije tetanusa, ki vstopajo skozi globoko rano.
Primary 2-4-6 months and booster at 12-24 months 
Primarno pri 2-4-6 mesecih in obnovitveni odmerek po 12 do 24 mesecih
Hexacima must not be mixed with any other vaccines or other parenterally administered medicinal products. 
Cepiva Hexaxim ne smemo mešati z drugimi cepivi ali drugimi parenteralno apliciranimi zdravili.
If your child misses a scheduled injection, it is important that you discuss with your doctor or nurse who will decide when to give the missed dose. 
Če vaš otrok zamudi predvideni odmerek je pomembno, da se pogovorite s svojim zdravnikom ali medicinsko sestro, ki bosta določila, kdaj naj otrok prejme izpuščeni odmerek.
3 Or equivalent activity determined by an immunogenicity evaluation 4 Produced on Vero cells 
3 Ali enakovredna aktivnost, določena z oceno imunogenosti.
Months N=249** N=204† N=178†† N=177 to 
3-5 mesecev 6-10-14 tednov mesecev mesecev N = 249** N = 204† N = 178†† N = 177 do
Immunisation should be postponed in individuals suffering from moderate to severe acute febrile illness or infection. 
Cepljenje je treba prestaviti, kadar ima posameznik zmerno ali hudo vročinsko akutno bolezen ali okužbo.
PHARMACEUTICAL FORM Suspension for injection. 
FARMACEVTSKA OBLIKA suspenzija za injiciranje.
Hexacima is given as an injection into a muscle (intramuscular route IM) in the upper part of your child's leg or upper arm. 
Cepivo Hexacima se daje kot injekcija v mišico (intramuskularna pot uporabe - i. m.) v zgornji del otrokove noge ali nadlahti.
For syringes without an attached needle, the needle must be fitted firmly to the syringe, rotating it by a one-quarter turn. 
Pri injekcijskih brizgah brez pritrjene igle morate iglo trdno pritrditi na injekcijsko brizgo tako, da jo zavrtite za četrt obrata.
Tetanus Toxoid not less than 40 IU2,3 
tetanusni toksoid ne manj kot 40 i.e.2,3
• Tetanus Toxoid 
• tetanusni toksoid
Like all medicines, this vaccine can cause side effects, although not everybody gets them. 
Možni neželeni učinki Kot vsa zdravila ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
It is important to follow the instructions from the doctor or nurse so that your child completes the course of injections. 
Pomembno je, da sledite navodilom zdravnika ali medicinske sestre tako, da bo vaš otrok zaključil celotno shemo cepljenja.
Table 1: Adverse Reactions from clinical trials and reported during commercial use System Organ Class 
Tabela 1: Neželeni učinki iz kliničnih študij in poročanja po prihodu zdravila na trg
Booster doses should be given at least 6 months after the last priming dose and in accordance with the official recommendations. 
Obnovitvene odmerke je treba dati najmanj v 6 mesecih po osnovnem cepljenju skladno z uradnimi priporočili.
The recommended injection site is preferably the antero-lateral area of the upper thigh and the deltoid muscle in older children (possibly from 15 months of age). 
Priporočena mesta za injiciranje so zgornji anterolateralni predel stegna in deltoidna mišica pri starejših otrocih (po možnosti od 15 meseca starosti dalje).
The immune responses to Hib (PRP) and pertussis antigens (PT and FHA) were evaluated after 2 doses in a subset of subjects receiving Hexacima (N=148) at 2, 4, 6 months of age. 
Imunski odziv na Hib (PRP) in antigene oslovskega kašlja (PT in FHA) je bil ovrednoten po prejemu dveh odmerkov v podskupini, ki je prejemala Hexacima (N=148) pri starosti 2, 4 in 6 mesecev.
Hexacima can be given at the same time as other vaccines such as pneumococcal vaccines, measlesmumps-rubella vaccines, rotavirus vaccines or meningococcal vaccines. 
Cepivo Hexacima se lahko daje istočasno kot druga cepiva, kot so polisaharidna konjugirana cepiva proti pnevmokokom, cepiva proti ošpicam, mumpsu in rdečkam, cepiva proti rotavirusom ali cepiva proti meningokokom.
• Hexacima will not protect against hepatitis infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E. 
• Cepivo Hexacima ne ščiti pred okužbo s hepatitisom, ki ga povzročajo drugi agensi, kot so hepatitis A, hepatitis C in hepatitis E.
Hexacima is available in pack containing 10 vials. 
Cepivo Hexacima je na voljo v pakiranju, ki vsebuje 10 vial.
• suffered from a severe reaction affecting the brain (encephalopathy) within 7 days of a prior dose of a pertussis vaccine (acellular or whole cell pertussis). 
• trpel zaradi hude reakcije na možganih (encefalopatija) v 7 dneh po predhodnem odmerku cepiva proti oslovskemu kašlju (brezceličnega ali s celimi celicami).
The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B. 
Cepivo lahko vsebuje sledove gluteraldehida, formaldehida, neomicina, streptomicina ali polimiksina B.
First course of vaccination (primary vaccination) Your child will receive either two injections given at an interval of two months or three injections given at an interval of one to two months (at least four weeks apart). 
Vaš otrok bo prejel ali dve injekciji v razmiku dveh mesecev ali tri injekcije v razmiku enega do dveh mesecev (vsaj štiri tedne narazen).
The presence of a minor infection and/or low-grade fever should not result in the deferral of vaccination. 
Blaga okužba in/ali nekoliko zvišana telesna temperatura ne smeta biti vzrok za odložitev cepljenja.
Pack of 10. 
Pakiranje po 10.
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, okužbo pljuč (bronhitis), ki lahko traja zelo dolgo, pljučno okužbo (pljučnico), krče, poškodbe možganov in celo smrt.
• Hepatitis B is caused by the hepatitis B virus. 
• Hepatitis B povzroča virus hepatitisa B. Povzroča oteklino (vnetje) jeter.
The long term capability of the acellular pertussis (aP) antigens contained in Hexacima to reduce pertussis incidence and control pertussis disease in the childhood has been demonstrated in a 10-year national pertussis surveillance on pertussis disease in Sweden with the pentavalent DTaP-IPV/Hib vaccine using a 3, 5, 12 months schedule. 
Dolgoročno zmožnost brezceličnih antigenov oslovskega kašlja, ki jih vsebuje cepivo Hexacima, za zmanjšanje incidence oslovskega kašlja in nadzor bolezni v otroštvu so dokazali v desetletnem nacionalnem spremljanju oslovskega kašlja na Švedskem s petvalentnim cepivom DTaP-IPV/Hib z uporabo 3, 5, 12 mesečne sheme.
All vaccination schedules including the WHO Expanded Program on Immunisation (EPI) at 6, 10, 14 weeks of age can be used whether or not a dose of hepatitis B vaccine has been given at birth. 
Vse sheme cepljenja vključno z Razširjenim imunizacijskim programom SZO (EPI - Expanded Program on Immunisation) pri starosti 6, 10 in 14 tednov, se lahko uporabijo ne glede na to, ali je bil otrok cepljen proti hepatitisu B že ob rojstvu ali ne.
Immune responses to Hib and pertussis antigens after 2 doses at 2 and 4 months of age 
Imunski odzivi na antigena Hib in oslovskega kašlja po 2 odmerkih v starosti 2 in 4 mesece
• This vaccine does not protect against infections caused by other types of Haemophilus influenzae nor against meningitis due to other micro-organisms. 
• Cepivo ne ščiti pred okužbami, ki jih povzročajo drugi tipi Haemophilusa influenzae, ali pred meningitisom, ki ga povzročajo drugi mikroorganizmi.
The vaccine effectiveness against Hib invasive disease of DTaP and Hib combination vaccines (pentavalent and hexavalent including vaccines containing the Hib antigen from Hexacima) has been demonstrated in Germany via an extensive (over five years follow-up period) post-marketing surveillance study. 
Uspešnost zaščite pred invazivnimi boleznimi, ki jih povzroča Hib Učinkovitost kombiniranih cepiv proti DTaP in Hib (pentavalentna in heksavalentna cepiva, vključno s cepivi, ki vsebujejo enak antigen Hib kot cepivo Hexacima) proti invazivnim boleznim, ki jih povzroča Hib, so dokazali v Nemčiji z obširno (več kot petletno obdobje spremljanja) opazovalno študijo v obdobju trženja.
• A dose of 0.5 ml is withdrawn using a syringe for injection 
• Odmerek 0,5 ml se daje z uporabo injekcijske brizge.
Slightly higher solicited reactogenicity was observed after the first dose compared to subsequent doses. 
Po prejemu prvega odmerka je bila pri posameznikih opažena nekoliko višja reaktogenost v primerjavi z kasnejšimi odmerki.
Booster vaccination at 11-12 months of age after a two doses primary course 
Obnovitveno cepljenje pri starosti 11 - 12 mesecih po osnovnem cepljenju z dvema odmerkoma
1 pre-filled syringe (0.5 ml) without needle 10 pre-filled syringes (0.5 ml) without needle 1 pre-filled syringe (0.5 ml) with 1 needle 10 pre-filled syringes (0.5 ml) with 10 needles 1 pre-filled syringe (0.5 ml) with 2 needles 10 pre-filled syringes (0.5 ml) with 20 needles 
1 napolnjena injekcijska brizga (0,5 ml) brez injekcijske igle 10 napolnjenih injekcijskih brizg (0,5 ml) brez injekcijske igel 1 napolnjena injekcijska brizga (0,5 ml) z 1 injekcijsko iglo 10 napolnjenih injekcijskih brizg (0,5 ml) z10 injekcijskimi iglami 1 napolnjena injekcijska brizga (0,5 ml) z 2 injekcijskima iglama 10 napolnjenih injekcijskih brizg (0,5 ml) z 20 injekcijskimi iglami
STATEMENT OF ACTIVE SUBSTANCE(S) One dose1 (0.5 ml) contains: 
En odmerek1 (0,5 ml) vsebuje:
• Pertussis (often called whooping cough) is a highly infectious illness that affects the airways. 
• Oslovski kašelj (pogosto imenovan pertusis) je zelo nalezljiva bolezen, ki prizadene dihalne poti.
These reactions start within 24-72 hours after vaccination, may be associated with redness, warmth, tenderness or pain at the injection site, and get better within 3-5 days without the need for treatment. 
Te reakcije se pojavijo v 24-72 urah po cepljenju, lahko so povezane s pordelostjo, toploto, občutljivostjo ali bolečino na mestu injiciranja in se izboljšajo v 3-5 dneh brez potrebe po zdravljenju.
• Shake the pre-filled syringe so that the contents become homogeneous. 
• Napolnjeno injekcijsko brizgo pretresite, da se vsebina homogenizira.
Table 3: Seroprotection ratesa at the age of 4.5 years old after vaccination with Hexacima Antibody Thresholds 
Preglednica 3: Deleži serološke zaščite a v starosti 4,5 leta po cepljenju s cepivom Hexacima
Vaccine efficacy of the acellular pertussis (aP) antigens contained in Hexacima against the most severe WHO-defined typical pertussis (≥ 21 days of paroxysmal cough) is documented in a randomised double-blind study among infants with a 3 dose primary series using a DTaP vaccine in a highly endemic country (Senegal). 
Učinkovitost cepiva z brezceličnimi antigeni oslovskega kašlja (aP), ki jih vsebuje cepivo Hexacima, proti tipičnemu oslovskemu kašlju v skladu z definicijo SZO (napadi kašlja, ki trajajo ≥ 21 dni), je dokumentirana v randomizirani dvojno slepi študiji pri dojenčkih z osnovno serijo treh odmerkov s cepivom DTaP v visoko endemični državi (Senegal).
1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 
1 Adsorbiran na hidratirani aluminijev hidroksid (0,6 mg Al3+)
Anti-diphtheria (≥ 0.01 IU/ml) (≥ 0.1 IU/ml) Anti-tetanus (≥ 0.01 IU/ml) (≥ 0.1 IU/ml) Anti-PTe (≥ 8 EU/ml) Anti-FHAe (≥ 8 EU/ml) Anti-HBs (≥ 10 mIU/ml) Anti-Polio type 1 (≥ 8 (1/dilution)) 
Antidifterijsko (≥ 0,01 i.e./ml) (≥ 0,1 i.e./ml) Antitetanusno (≥ 0,01 i.e./ml) (≥ 0,1 i.e./ml) Anti-PTe (≥ 8 E.e./ml) Anti-FHAe (≥ 8 E.e./ml) Anti-HBs (≥ 10 mi.e./ml) Antipolio tip 1
Studies on long-term persistence of vaccine induced antibodies following varying infant / toddler primary series and following Hepatitis B vaccine given at birth or not have shown maintenance of levels above the recognized protective levels or antibody thresholds for the vaccine antigens (see Table 3). 
Študije dolgoročne ohranitve s cepivom izzvanih protiteles, po različnih primarnih zaporedjih cepljenj dojenčkov/malih otrok in po cepljenju proti hepatitisu B ob rojstvu ali brez cepljenja proti hepatitisu B ob rojstvu, so pokazale, da se raven protiteles ohrani nad priznanimi zaščitnimi ravnmi ali nad pragom protiteles za antigene cepiv (glejte preglednico 3).
• Poliomyelitis (often just called polio) is caused by viruses that affect the nerves. 
• Otroško paralizo (imenovano tudi poliomielitis) povzročajo virusi, ki prizadenejo živce.
Vaccination with Hexacima is contraindicated if the individual has experienced an encephalopathy of unknown aetiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine (whole cell or acellular pertussis vaccines). 
Cepljenje s cepivom Hexacima je kontraindicirano, če je dojenček prebolel encefalopatijo neznanega izvora, ki se je pojavila v 7 dneh po predhodnem cepljenju s cepivom, ki je vsebovalo tudi cepivo proti oslovskemu kašlju (cepivo proti oslovskemu kašlju s celimi celicami ali acelularno).
In the event of any foreign particulate matter and/or variation of physical aspect being observed, discard the vial. 
V primeru prisotnosti kakršnihkoli tujih delcev in/ali neobičajnega fizikalnega videza zavrzite vialo.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/828/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/828/001
What Hexacima looks like and contents of the pack 
Izgled cepiva Hexacima in vsebina pakiranja
After shaking, the normal appearance of the vaccine is a whitish cloudy suspension. 
Ko pretresete cepivo, je njegov normalni videz belkasta, motna suspenzija.
Hepatitis B surface antigen6 
površinski antigen hepatitisa B6
Anti-HBs (≥ 10 mIU/ml) 
Protitelesa proti HBs (≥ 10 m i.e./ml)
• Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination; 
• stalen, neutolažljiv jok, ki traja ≥ 3 ure in se pojavi v 48 urah po cepljenju;
• Hexacima must be administered intramuscularly. 
• Cepivo Hexacima se daje intramuskularno.
Poliovirus (Inactivated) 4 Type 1 (Mahoney) 
25 mikrogramov poliovirus (inaktiviran)4 tip 1 (sev Mahoney)
Hexacima does not protect against infectious diseases caused by other types of Haemophilus influenzae or against meningitis of other origins. 
Cepivo Hexacima ne ščiti pred nalezljivimi boleznimi, ki jih povzročajo drugi tipi Haemophilusa influenzae, ali pred meningitisom drugačnega izvora.
These reactions start within 24-72 hours after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site and resolve spontaneously within 3-5 days. 
Te reakcije se pojavijo v 24-72 urah po cepljenju, lahko so povezane z pordelostjo, toploto, občutljivostjo ali bolečino na mestu injiciranja in minejo spontano v 3-5 dneh.
Hexacima suspension for injection in pre-filled syringe Hexacima suspension for injection 
Hexacima suspenzija za injiciranje v napolnjeni injekcijski brizgi Hexacima suspenzija za injiciranje
Table 1: Seroprotection/Seroconversion rates* one month after primary vaccination with 2 or 3 doses of Hexacima 
Preglednica 1: Stopnja serozaščite/serokonverzije* en mesec po osnovnem cepljenju z 2 ali 3 odmerki cepiva Hexacima
5 Equivalent antigenic quantity in the vaccine 6 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology 
6 Pridobljen v celicah kvasovke Hansenula polymorpha s tehnologijo rekombinantne DNA.
Manufacturer: Sanofi Pasteur, 1541 avenue Marcel Mérieux, 69280 Marcy l'Etoile, France 
Izdelovalca: Sanofi Pasteur, 1541 avenue Marcel Mérieux, 69280 Marcy l'Etoile, Francija
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Hexacima - Carton for vial. 
PODATKI NA ZUNANJI OVOJNINI Hexacima - škatla z vialami.
Table 2: Seroprotection/Seroconversion rates* one month after booster vaccination with Hexacima 
Preglednica 2: Stopnja serozaščite/serokonverzije* en mesec po obnovitvenem cepljenju s cepivom Hexacima
Sanofi Pasteur, Parc Industriel d'Incarville, 27100 Val de Reuil, France 
Sanofi Pasteur, Parc Industriel d'Incarville, 27100 Val de Reuil, Francija
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, je treba uporabiti monovalentno cepivo proti hepatitisu B.
Sanofi Pasteur Parc Industriel d'Incarville 27100 Val de Reuil France 
Sanofi Pasteur Parc Industriel d'Incarville 27100 Val-de-Reuil Francija
Non-clinical data reveal no special hazard for humans based on conventional repeat dose toxicity and local tolerance studies. 
Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih in študij lokalne tolerance ne kažejo posebnega tveganja za človeka.
At the very least, a dose of Hib vaccine must be administered. 
Najmanj je treba cepiti z obnovitvenim odmerkom Hib cepiva.
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse. 
Če imate dodatna vprašanja o uporabi cepiva, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
The bacteria that cause the disease also make a toxin (poison) that can damage the heart, kidneys and nerves. 
proizvajajo tudi toksin (strup), ki lahko poškoduje srce, ledvice in živce.
N=322†† N=934 to 
N = 249** N = 123 do 220† N = 322†† N = 934 do
Hexacima is provided as a suspension for injection in vial (0.5 ml). 
Cepivo Hexacima je na voljo kot suspenzija za injiciranje v viali (0,5 ml).
Hexacima in vials 
Cepivo Hexacima v vialah
Data on concomitant administration of Hexacima with a meningococcal C conjugate vaccine or a meningococcal group A, C, W-135 and Y conjugate vaccine have shown no clinically relevant interference in the antibody response to each of the antigens. 
Podatki o sočasnem dajanju cepiva Hexacima z meningokoknim C konjugiranim cepivom ali z meningokoknim konjugiranim cepivom skupin A, C, W-135 in Y niso pokazali klinično pomembnih sprememb odziva protiteles na posamezne antigene.
Booster vaccination during the second year of life following a three dose primary course 
Obnovitveno cepljenje v drugem letu starosti po treh odmerkih osnovnega cepljenja
Hexacima suspension for injection 
Hexacima suspenzija za injiciranje
In the event of any foreign particulate matter and/or variation of physical aspect being observed, discard the pre-filled syringe. 
V primeru prisotnosti kakršnihkoli tujih delcev in/ali neobičajnega fizikalnega videza zavrzite napolnjeno injekcijsko brizgo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Hexacima - Carton for pre-filled syringe without needle, with one separate needle, with two separate needles. 
Hexacima - škatla z napolnjeno injekcijsko brizgo brez igle, z eno ločeno iglo, z dvema ločenima iglama.
Hexacima is a whitish, cloudy suspension. 
Cepivo Hexacima je belkasta, motna suspenzija.
If any of the following events are known to have occurred after receiving any pertussis containing vaccine, the decision to give further doses of pertussis containing vaccine should be carefully considered: 
Če je znano, da se je v določenem času po prejemu kateregakoli cepiva s komponento proti oslovskemu kašlju pojavil katerikoli izmed naslednjih neželenih učinkov, je treba temeljito pretehtati odločitev o dajanju nadaljnjih odmerkov cepiva s komponento proti oslovskemu kašlju:
Where a dose of hepatitis B vaccine is given at birth, Hexacima can be used for supplementary doses of hepatitis B vaccine from the age of six weeks. 
Če je bil otrok cepljen proti hepatitisu B ob rojstvu, se cepivo Hexacima lahko uporabi za dodatne odmerke cepiva proti hepatitisu B od starosti šestih tednov dalje.
Hexacima may be used as a booster in individuals who have previously been vaccinated with another hexavalent vaccine or a pentavalent DTaP-IPV/Hib vaccine associated with a monovalent hepatitis B vaccine. 
Cepivo Hexacima se lahko uporabi za obnovitveno cepljenje posameznikov, ki so bili pred tem cepljeni z drugim šestvalentnim cepivom ali petvalentnim cepivom DTaP-IPV/Hib povezanim z monovalentnim cepivom proti hepatitisu B.
Bordetella pertussis antigens Pertussis Toxoid 
antigene Bordetelle pertussis toksoid oslovskega kašlja
A dose of 0.5 ml is withdrawn using a syringe for injection. 
Odmerek 0,5 ml iz viale odvzemite s pomočjo injekcijske brizge.
• Hepatitis B surface antigen 
• površinski antigen hepatitisa B
• Bordetella pertussis antigens : Pertussis Toxoid/Filamentous Haemagglutinin 25/25 µg 
• antigene Bordetelle pertussis: toksoid oslovskega kašlja/ filamentozni hemaglutinin
• Convulsions with or without fever, occurring within 3 days of vaccination. 
• krči z zvišano telesno temperaturo ali brez nje, ki so se pojavili v treh dneh po cepljenju.
When a dose of hepatitis B vaccine is given at birth, the sequential infant primary vaccination hexavalent/pentavalent/hexavalent schedule with Hexacima and a pentavalent DTaP-IPV/Hib vaccine can be used in accordance with official recommendations. 
Če je bil ob rojstvu uporabljen odmerek cepiva proti hepatitisu B, je mogoče za zaporedno primarno cepljenje dojenčka uporabiti razpored heksavalentno/pentavalentno/heksavalentno s cepivom Hexacima in pentavalentnim cepivom DTaP-IPV/Hib v skladu z uradnimi priporočili.
Otherwise, post-vaccination antibody concentration should be ≥ pre immunisation level 
Sicer pa naj bi bila koncentracija protiteles po cepljenju ≥ izmerjeni pred imunizacijo.
Precautions for use 
Previdnostni ukrepi pri uporabi
Suspension for injection in pre-filled syringe. 
suspenzija za injiciranje v napolnjeni injekcijski brizgi.
There may be a clinically relevant interference in the antibody response of Hexacima and a varicella vaccine and these vaccines should not be administered at the same time. 
Klinično pomembne spremembe odziva protiteles se lahko pojavijo pri sočasni uporabi cepiv Hexacima in cepiva proti noricam, zato ju ne smemo uporabljati istočasno.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
D. POGOJI IN OMEJITVE GLEDE VARNOSTI IN UČINKOVITOSTI ZDRAVILA
• Very common side effects (may affect more than 1 in 10 people) are: - loss of appetite (anorexia) - crying - sleepiness (somnolence) - vomiting - pain, redness or swelling at the injection site - irritability - fever (temperature 38°C or higher) 
• Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 cepljenih) so: - izguba apetita (anoreksija) - jok - zaspanost (solmolenca) - bruhanje - bolečina, pordelost ali oteklina na mestu injiciranja; - razdražljivost