natgillin/translations-raw huggingface dataset:
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• A dose of 0.5 ml is withdrawn using a syringe for injection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
To make sure that Hexacima is suitable for your child, it is important to talk to your doctor or nurse if any of the points below apply to your child.
Kaj morate vedeti, preden bo vaš otrok prejel cepivo Hexacima Da bi se prepričali, da je cepivo Hexacima primerno za vašega otroka, je pomembno, da se pogovorite z zdravnikom ali medicinsko sestro, če kaj od spodaj navedenega velja za vašega otroka.
Hexacima in pre-filled syringes EU/1/13/828/002
Cepivo Hexacima v napolnjenih injekcijskih brizgah EU/1/13/828/002
In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria, tetanus, hepatitis B, poliomyelitis and Hib vaccines.
V takih primerih je treba cepljenje proti oslovskemu kašlju opustiti, cepljenje pa nadaljevati s cepivi proti davici, tetanusu, hepatitisu B, otroški paralizi in hemofilusu influence tipa b.
Hexacima 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.
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, saj se hepatitis D (ki ga povzroča agens delta) ne pojavi v odsotnosti okužbe s hepatitisom B.
Hexacima is provided as a suspension for injection in pre-filled syringe (0.5 ml).
Cepivo Hexacima je na voljo kot suspenzija za injiciranje v napolnjeni injekcijski brizgi (0,5 ml).
In individuals with chronic renal failure, an impaired hepatitis B response is observed and administration of additional doses of hepatitis B vaccine should be considered according to the antibody level against hepatitis B virus surface antigen (anti-HBsAg).
Pri posameznikih s kronično ledvično odpovedjo opažajo slabši odziv pri hepatitisu B, zato je treba glede na količino protiteles proti površinskemu antigenu virusa hepatitisa B (anti-HBsAg) razmisliti o dajanju dodatnih odmerkov cepiva proti hepatitisu B.
The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Pri aplikaciji osnovne serije imunizacije zelo prezgodaj rojenim nedonošenčkom (rojenim v 28. tednu gestacije ali prej), še zlasti tistim z respiratorno nezrelostjo v anamnezi, je treba upoštevati morebitno tveganje za apnejo in je potrebo spremljanje pljučnega delovanja od 48 do 72 ur po cepljenju.
• Temporary inflammation of nerves causing pain, paralysis and sensitivity disorders (GuillainBarré syndrome) and severe pain and decreased mobility of arm and shoulder (brachial neuritis) have been reported after administration of a tetanus containing vaccine.
• začasno vnetje živcev, ki povzroča bolečino, paralizo in motnje občutljivosti (Guillain-Barré sindrom) ter hudo bolečino in omejeno mobilnost roke in rame (brahialni nevritis) po injiciranju cepiva, ki vsebuje komponento tetanusa
Immune memory against Hepatitis B had been demonstrated by the presence of an anamnestic response to a challenge Hepatitis B vaccination at the age of 9 years in 93% of vaccinees with development of geometric mean concentrations at 3692 (95% CI: 1886 - 7225) mIU/ml after vaccination.
9 let pri 93 % cepljenih, s pojavom geometrične srednje koncentracije 3692 (95 % IZ: 1886-7225) mi.e./ml po cepljenju.
No data are available for premature infants.
Podatkov o nedonošenčkih ni na voljo.
When given at the same time with other vaccines, Hexacima will be given at different injection sites.
Če se cepljenje opravlja sočasno z drugim cepivom, bo cepivo Hexacima injicirano na različno mesto.
• Haemophilus influenzae type b polysaccharide
• polisaharid hemofilusa influence tipa b
Pharmaco-therapeutic group: Vaccines, Bacterial and viral vaccines combined, ATC code: J07CA09 The immunogenicity of Hexacima in children over 24 months of age has not been studied in clinical trials.
Farmakoterapevtska skupina: Cepiva, kombinacije bakterijskih in virusnih cepiv, oznaka ATC: J07CA09
Hexacima will be given to your child by a doctor or nurse trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection (see section 4 Possible side effects).
Kako uporabljati cepivo Hexacima Cepivo Hexacima bo vašemu otroku injiciral zdravnik ali medicinska sestra, saj sta usposobljen za uporabo cepiv in za obravnavo vseh občasnih hudih alergijskih reakcij na injekcijo.
Hexacima in vials EU/1/13/828/001
Cepivo Hexacima v vialah EU/1/13/828/001
• previously had Guillain-Barré syndrome (temporary inflammation of nerves causing pain, paralysis and sensitivity disorders) or brachial neuritis (severe pain and decreased mobility of arm and shoulder) after being given a vaccine containing tetanus toxoid (an inactivated form of tetanus toxin).
• v preteklosti imel Guillain-Barréjev sindrom (prehodno vnetje živcev, ki povzroča bolečino, paralizo in nenormalno občutljivost) ali brahialni nevritis (hude bolečine in zmanjšanje mobilnosti roke in ramena) po prejemu predhodnega cepiva, ki je vsebovalo tetanusni toksoid
The administration of Hexacima must be carefully considered in individuals who have a history of serious or severe reactions within 48 hours following administration of a vaccine containing similar components.
Pri posameznikih z anamnezo resnih oziroma hudih reakcij v 48 urah po predhodni injekciji cepiva, ki je vsebovalo podobne komponente, je treba skrbno premisliti o cepljenju s cepivom Hexacima.
How to store Hexacima
Shranjevanje cepiva Hexacima
• Very rare side effects (may affect up to 1 in 10,000 people) are: - episodes when your child goes into a shock-like state or is pale, floppy and unresponsive for a period of time (hypotonic reactions or hypotonic hyporesponsive episodes HHE).
- epizode, pri katerih je vaš otrok v šoku podobnem stanju oziroma je določen čas bled, mlahav in neodziven (hipotonične reakcije ali hipotonično-hiporesponzivne epizode
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja redki izpuščaj
8 D antigen units5
8 D-antigenskih enot5
(0.5 ml) contains: Diphtheria Toxoid not less than 20 IU2
Zdravilne učinkovine na odmerek (0,5 ml)1 so: davični toksoid ne manj kot 20 i.e.2
Other side effects not listed above have been reported occasionally with other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines and not directly with Hexacima:
Možni neželeni učinki O drugih neželenih učinkih, ki niso navedeni zgoraj, poročajo občasno pri drugih cepivih, ki vsebujejo cepiva proti davici, tetanusu, oslovskemu kašlju, otroški paralizi, hepatitisu B ali hemofilusu influence tipa b vendar ne neposredno pri uporabi cepiva Hexacima:
Hexacima (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).
Cepivo Hexacima (DTaP-IPV-HB-Hib) je indicirano za osnovno in obnovitveno cepljenje dojenčkov in malčkov, starejših od šest tednov, proti davici, tetanusu, oslovskemu kašlju, hepatitisu B,
A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Hexacima.
Anamneza vročinskih krčev in družinska anamneza krčev ali sindroma nenadne smrti dojenčka (SIDS
32 D antigen units5
32 D-antigenskih enot5