natgillin/translations-raw huggingface dataset:
• if after previously having Infanrix hexa or another vaccine against pertussis (whooping cough) disease, 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 ♦ Seizures/fits with or without a high temperature within 3 days of vaccination • if your child is suffering from an undiagnosed or progressive disease of the brain or uncontrolled epilepsy.
• če je po predhodnem cepljenju z Infanrixom 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 ♦ če je v 48 urah po cepljenju vztrajno in neutolažljivo jokal 3 ure ali dlje ♦ epileptične napade/ krče z ali brez zvišane telesne temperature v 3 dneh po cepljenju • če ima vaš otrok nediagnosticirano ali napredujočo bolezen možganov ali nenadzorovano epilepsijo.
After control of the disease the vaccine should be administered. • if your child has a bleeding problem or bruises easily • if your child has a tendency to seizures/fits due to a fever, or if there is a history in the family of this As with all vaccines, Infanrix hexa may not completely protect all people who are vaccinated.
Cepivo mora prejeti, ko je bolezen pod nadzorom. • če ima vaš otrok težave s krvavitvami ali hitrim nastankom modric • če je vaš otrok nagnjen k epileptičnim napadom/ krčem zaradi zvišane telesne temperature ali pa se je to pojavljalo v družini Tako kot velja za vsa cepiva, tudi Infanrix hexa ne zagotovi nujno popolne zaščite vsem cepljenim.
Your child will receive a total of two or three injections with an interval of at least one month between each one.
43 Vaš otrok bo prejel skupaj dva ali tri odmerke z vsaj enomesečnim vmesnim presledkom.
42 If additional injections or “booster” are necessary, the doctor will tell you.
Zdravnik vam bo povedal, če je potreben še dodatni ali "obnovitveni" odmerek.
As with all injectable vaccines, there is an extremely small risk of serious allergic reactions (anaphylactic and anaphylactoid reactions).
Kot pri vseh cepivih, ki jih injiciramo, obstaja tudi v tem primeru izjemno majhno tveganje resnih preobčutljivostnih reakcij.
Such reactions will usually occur before leaving the doctor’s surgery.
Takšne reakcije se bodo običajno pojavile še preden boste zapustili ordinacijo.
Uncommon (These may occur in up to 1 in 100 doses of the vaccine) • sleepiness • cough • large swelling at the injected limb.
Občasni (pojavijo se lahko pri največ 1 od 100 odmerkov cepiva) • zaspanost • kašelj
Rare (These may occur in up to 1 in 1,000 doses of the vaccine) • rash.
44 • močna oteklost uda, v katerega je bilo injicirano cepivo.
43 • 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. • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema) • dermatitis • swelling of the entire injected limb, vesicles at the injection site.
Zelo redki (pojavijo se lahko pri največ 1 od 10. 000 odmerkov cepiva) • oteklost bezgavk na vratu, v pazduhah ali dimljah (limfadenopatija) • 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 • otekanje obraza, ustnic, ust, jezika ali žrela, ki lahko povzroči težave s požiranjem ali dihanjem (angioedem) • dermatitis • oteklost celotnega uda, v katerega je bilo injicirano cepivo, mehurčki na mestu injiciranja.
conjugated to tetanus toxoid as carrier protein 1
vezan na tetanusni toksoid kot nosilni protein 1 adsorbiran na hidratirani aluminijev hidroksid (Al( OH) 3) 0, 5 miligrama Al 2
adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
pridobljen tehnologijo rekombinantne DNA na celični kulturi Saccharomyces 3
0.5 milligrams Al
cerevisiae
adsorbed on aluminium phosphate (AlPO4)
adsorbiran na aluminijev fosfat (AlPO4)
0.32 milligrams Al
0, 32 miligrama Al
4 propagated in VERO cells
4 namnožen v celicah VERO
- The other ingredients in Infanrix hexa are:
- Druge sestavine cepiva Infanrix hexa so:
44 What Infanrix hexa looks like and contents of the pack
Izgled cepiva Infanrix hexa in vsebina pakiranja
The Hib component is a white powder presented in a glass vial with Bioset®.
Hib komponenta je bel prašek v stekleni viali.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
46 Za vse morebitne nadaljnje informacije o tem cepivu se lahko obrnete na predstavništvo imetnika dovoljenja za promet s cepivom:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Podrobne informacije o cepivu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /. ---------------------------------------------------------------------------------------------------------------------
46 The DTPa-HBV-IPV suspension should be inspected visually for any foreign particulate matter and/or variation of physical aspect.
Preveriti morate videz suspenzije DTPa- HBV- IPV glede morebitne prisotnosti tujih delcev in/ ali neobičajnega fizikalnega videza cepiva.
The Bioset® is a specially designed cap which simplifies reconstitution.
Bioset je posebno oblikovana zaporka, ki poenostavi rekonstitucijo.
For reconstitution, twist the cover from the Bioset® cap and remove the cap from the syringe.
Za rekonstitucijo cepiva odstranite plastični pokrov Bioseta in odstranite pokrovček z injekcijske brizge.
Push downwards until syringe ‘clicks’ into position.
Vbrizgajte vsebino injekcijske brizge v vialo.
Inject liquid, mix thoroughly until powder is completely dissolved.
Mešanico dobro pretresite, da se prašek (Hib) popolnoma raztopi.
Aspirate reconstituted vaccine back into syringe.
Potegnite rekonstituirano cepivo nazaj v injekcijsko brizgo.
Affix a needle for administration.
Odvijte brizgo z Bioseta in pritrdite iglo za injiciranje cepiva.
The reconstituted vaccine presents as a slightly more cloudy suspension than the liquid component alone.
48 Rekonstituirano cepivo je na videz bolj motna suspenzija kot sama tekoča komponenta.
It contains the following active substances: toxoids (chemically weakened toxins) from diphtheria and tetanus, parts of Bordetella pertussis (a bacterium that causes whooping cough), parts of the hepatitis B virus and inactivated (killed) polioviruses.
Vsebuje naslednje zdravilne učinkovine: toksoide (kemično oslabljene toksine) davice in tetanusa, dele Bordetella pertussis (bakterije, ki povzroča oslovski kašelj), dele virusa hepatitisa B in inaktivirane (mrtve) polioviruse.
Infanrix Penta is used to vaccinate infants under three years of age against diphtheria, tetanus, pertussis (whooping cough), hepatitis B and poliomyelitis (polio).
Zdravilo Infanrix Penta se uporablja za cepljenje dojenčkov, mlajših od treh let, proti davici, tetanusu, oslovskemu kašlju, hepatitisu B in otroški ohromelosti (polio).
The recommended vaccination schedule for Infanrix Penta is two or three doses, given at least one month apart, usually within the first six months of life.
Priporočena shema cepljenja s cepivom Infanrix Penta sta dva do trije odmerki z najmanj enomesečnim presledkom med njimi, običajno v prvih šestih mesecih življenja.
The site of injection should be alternated for subsequent injections.
Mesto injiciranja je treba pri naslednjih injekcijah spremeniti.
A booster dose of Infanrix Penta or a similar vaccine must be given at least six months after the last dose of the initial course.
Obnovitveni odmerek cepiva Infanrix Penta ali podobnega cepiva je treba dati vsaj šest mesecev po zadnjem odmerku začetne sheme cepljenja.
The choice of which vaccine to use depends on official recommendations.
Izbira cepiva je odvisna od uradnih priporočil.
Infanrix Penta can be given to infants who received a hepatitis B vaccine at birth.
Cepivo Infanrix Penta se lahko daje dojenčkom, ki so bili ob rojstvu cepljeni proti hepatitisu B.
Infanrix Penta contains small amounts of: • toxoids from the bacteria that cause diphtheria and tetanus; • toxoids and other proteins purified from B. pertussis; • surface antigen (proteins from the surface) of the hepatitis B virus; • inactivated polioviruses (types 1, 2 and 3).
Cepivo Infanrix Penta vsebuje majhne količine: • toksoidov iz bakterij, ki povzročajo davico in tetanus, • toksoidov in drugih beljakovin, prečiščenih iz B. pertussis, • površinskega antigena (beljakovin s površine) virusa hepatitisa B, • inaktiviranih poliovirusev (tipov 1, 2 in 3).
When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘ foreign’ and makes antibodies against them.
Ko bo oseba naslednjič izpostavljena bakterijam ali virusom, bo lahko imunski sistem hitreje izdelal protitelesa.
The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses.
Cepivo je adsorbirano.
This helps to protect against the diseases that these bacteria and viruses cause.
To pomeni, da so zdravilne učinkovine vezane na aluminijeve spojine, kar spodbudi boljši odziv.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Površinske antigene virusa hepatitisa B proizvajajo z metodo, znano kot 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
This means that the active substances are fixed onto aluminium compounds, to stimulate a better response.
„ tehnologija rekombinantne DNK “, pri kateri kvasovka prejme gen (DNK), s katerim lahko tvori beljakovine.
Infanrix Penta is a combination of components that have been available in the European Union (EU) in other vaccines: diphtheria, tetanus, pertussis and hepatitis B were available in Infanrix HepB from 1997 until 2005, and diphtheria, tetanus, pertussis and polioviruses are available in other vaccines.
Cepivo Infanrix Penta je kombinacija sestavin, ki so v Evropski uniji (EU) na voljo v drugih cepivih: davica, tetanus, oslovski kašelj in hepatitis B so bili na voljo v cepivu Infanrix HepB od leta 1997 do 2005, davica, tetanus, oslovski kašelj in poliovirusi pa so na voljo v drugih cepivih.
Infanrix Penta has been studied in 16 studies looking at the first course of vaccination.
Cepivo Infanrix Penta so raziskovali v 16 študijah, v katerih so proučevali prvo shemo cepljenja.
The studies involved over 10,000 infants, about three quarters of whom received Infanrix Penta, given according to various time schedules.
V študije je bilo vključenih več kot 10 000 dojenčkov, od katerih so približno tri četrtine prejele cepivo Infanrix Penta v različnih časovnih razporedih.
The main measure of effectiveness was the production of antibodies against the active substances after vaccination.
Glavno merilo učinkovitosti je bila tvorba protiteles proti učinkovinam po cepljenju.
After one month, between 86 and 100% of the infants had developed protective levels of antibodies against all of the active substances in Infanrix Penta.
Po enem mesecu je med 86% in 100% dojenčkov razvilo zaščitne ravni protiteles proti vsem učinkovinam v cepivu Infantrix Penta.
After booster vaccination, there was an increase in the number of infants with protective levels of antibodies against the active substances.
Po obnovitvenem cepljenju se je povečalo število dojenčkov z zaščitnimi ravnmi protiteles proti učinkovinam.
The most common side effects with Infanrix Penta (seen in more than 1 in 10 doses of the vaccine) are loss of appetite, fever of 38ºC or more, local swelling, pain and redness at the injection site, fatigue (tiredness), abnormal crying, irritability and restlessness.
Najpogostejši neželeni učinki cepiva Infanrix Penta (opaženi pri več kot 1 odmerku cepiva od 10) so izguba teka, telesna temperatura 38º C ali več, lokalna oteklina, bolečina in rdečina na mestu injiciranja, utrujenost, neobičajno jokanje, razdražljivost in nemir.
For the full list of all side effects reported with Infanrix Penta, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi cepiva Infanrix Penta, glejte navodilo za uporabo.
Infanrix Penta should not be used in infants who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients of the vaccine, or to neomycin and polymyxin (antibiotics), or if the infant has had an allergic reaction after a previous vaccine containing diphtheria, tetanus, pertussis, hepatitis B or polio.
Cepivo Infanrix Penta se ne sme uporabljati pri dojenčkih, ki utegnejo biti preobčutljivi za (alergični na) katero koli zdravilno učinkovino, katero koli drugo sestavino cepiva ali na neomicin in polimiksin (antibiotika), oziroma če je dojenček imel alergično reakcijo po prejšnjem cepivu, ki je vsebovalo dele bakterij ali virusov davice, tetanusa, oslovskega kašlja, hepatitisa B ali otroške ohromelosti (polio).
Infanrix Penta should not be given if the infant has had encephalopathy (brain disease) of unknown cause within seven days of a previous vaccination with a vaccine containing pertussis components.
Cepivo Infanrix Penta se ne sme uporabiti, če je dojenček prebolel encefalopatijo (možgansko bolezen) neznanega vzroka, ki se je pojavila v sedmih dneh po predhodnem cepljenju s cepivom, ki je vsebovalo sestavine oslovskega kašlja.
Infanrix Penta should be postponed in infants with a severe sudden fever.
Pri dojenčkih, ki imajo nenadno visoko telesno temperaturo, je treba cepljenje s cepivom Infanrix Penta odložiti.
As for all vaccines, if Infanrix Penta is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Kadar se cepivo Infanrix Penta uporabi pri veliko prezgodaj rojenih nedonošenčkih, obstaja nevarnost, kot pri cepljenju z drugimi cepivi, da dojenčki doživijo apnejo (kratke prekinitve dihanja).
The Committee for Medicinal Products for Human Use (CHMP) decided that Infanrix Penta’ s benefits are greater than its risks for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi cepiva Infanrix Penta za osnovno in obnovitveno cepljenje dojenčkov proti davici, tetanusu, oslovskemu kašlju, hepatitisu B in otroški ohromelosti večje od z njim povezanih tveganj.
The Committee recommended that Infanrix Penta be given marketing authorisation.
Odbor je priporočil, da se za cepivo Infanrix Penta odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the EU for Infanrix Penta to GlaxoSmithKline Biologicals s. a. on 23 October 2000.
Evropska komisija je dovoljenje za promet s cepivom Infanrix Penta, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s. a. dne 23. oktobra 2000.
The marketing authorisation was renewed on 23 October 2005.
Dovoljenje za promet z zdravilom je bilo obnovljeno 23. oktobra 2005.
EU/ 1/ 00/ 153/ 001
EU/ 1/ 00/ 153/ 001 Infanrix penta
Infanrix penta -1-
glejte *
Pre-filled syringe (glass)
napolnjena injekcijska
EU/ 1/ 00/ 153/ 002
EU/ 1/ 00/ 153/ 002 Infanrix penta
EU/ 1/ 00/ 153/ 003
EU/ 1/ 00/ 153/ 003 Infanrix penta
20 pre-filled syringes
20 napolnjenih injekcijskih
EU/ 1/ 00/ 153/ 004
EU/ 1/ 00/ 153/ 004 Infanrix penta
EU/ 1/ 00/ 153/ 005
EU/ 1/ 00/ 153/ 005 Infanrix penta
1 pre-filled syringe (glass) + 1 separate needle
1 napolnjena injekcijska brizga + 1
EU/ 1/ 00/ 153/ 006
EU/ 1/ 00/ 153/ 006 Infanrix penta
10 pre-filled syringes + 10 separate needles
10 napolnjenih injekcijskih brizg + 10
EU/ 1/ 00/ 153/ 007
EU/ 1/ 00/ 153/ 007 Infanrix penta
20 pre-filled syringes + 20 separate needles
20 napolnjenih injekcijskih brizg + 20
EU/ 1/ 00/ 153/ 008
EU/ 1/ 00/ 153/ 008 Infanrix penta
50 pre-filled syringes + 50 separate needles
50 napolnjenih injekcijskih brizg + 50
EU/ 1/ 00/ 153/ 009
EU/ 1/ 00/ 153/ 009 Infanrix penta
1 pre-filled syringe + 2 separate needles
(1 napolnjena injekcijska brizga z dvema
EU/ 1/ 00/ 153/ 010
EU/ 1/ 00/ 153/ 010 Infanrix penta
pre-filled syringe(glass)
napolnjena injekcijska
10 pre-filled syringes + 20 separate needles
priloženima injekcijskima iglama) x 10
-1-
40 i. e.
Diphtheria toxoid, adsorbed Tetanus toxoid, adsorbed Pertussis toxoid, adsorbed Filamentous haemagglutinin, adsorbed Pertactin, adsorbed Recombinant Hepatitis B surface
toksoid bordetele pertusis filamentozni hemaglutinin pertaktin površinski antigen virusa hepatitisa B, rekombinantni (S protein) inaktivirani poliovirus
≥ 30IU ≥ 40IU 25 micrograms 25 micrograms 8 micrograms
25 mikrogramov 25 mikrogramov 8 mikrogramov 10 mikrogramov
antigen (S protein), adsorbed Inactivated type 1 Poliovirus Inactivated type 2 Poliovirus Inactivated type 3 Poliovirus
tip 1 tip 2 tip 3
10 micrograms 40 DU 8 DU 32 DU
40 D- antigenskih enot 8 D- antigenskih enot 32 D- antigenskih enot
Infanrix Penta – Suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Infanrix Penta – suspenzija za injiciranje Adsorbirano cepivo proti davici (D), tetanusu (T), oslovskemu kašlju (brezcelično, pripravljeno iz antigenskih sestavin) (Pa), hepatitisu B (rekombinantno) (HBV) in otroški ohromelosti (inaktivirano) (IPV)
Pertussis toxoid1 Filamentous Haemagglutinin1 Pertactin1 Hepatitis B surface antigen2,3 Poliovirus (inactivated)
toksoid1 bordetele pertusis filamentozni hemaglutinin1 pertaktin1 površinski antigen virusa hepatitisa B2, 3 poliovirus (inaktivirani)
type 1 (Mahoney strain)4 type 2 (MEF-1 strain) 4 type 3 (Saukett strain) 4
tip 1 (sev Mahoney) 4 tip 2 (sev MEF- 1) 4 tip 3 (sev Saukett) 4
2
adsorbiran na hidratirani aluminijev hidroksid (Al( OH) 3) 2
0.5 milligrams Al
0. 5 mikrogramov Al
produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 3 4
pridobljen s tehnologijo rekombinantne DNA na celični kulturi Saccharomyces cerevisiae 3 adsorbiran na aluminijev fosfat (AlPO4) 4 namnožen v celicah VERO
0.2 milligrams Al
0. 2 mikrogramov Al
Suspension for injection Infanrix Penta is a turbid white suspension.
Suspenzija za injiciranje Infanrix Penta je motna bela suspenzija.
Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.
Infanrix Penta je indiciran za osnovno in obnovitveno cepljenje otrok proti davici, tetanusu, oslovskemu kašlju, hepatitisu B in otroški ohromelosti.
Infanrix Penta is not intended for use in children over 36 months of age.
Cepivo Infanrix Penta ni namenjeno za cepljenje otrok, starejših od 36 mesecev.
The primary vaccination schedule consists of three doses of 0.5 ml (such as 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) or two doses (such as 3, 5 months).
Shema osnovnega cepljenja sestoji iz treh odmerkov po 0, 5 ml (v 2., 3., 4. mesecu starosti; 3., 4., 5. mesecu starosti; 2., 4., 6. mesecu starosti) ali dveh odmerkov (v 3., 5. mesecu starosti).
2 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.
2 Drugačno shemo cepljenja (v 6., 10., 14. tednu starosti) se lahko uporabi le v primeru, če je bil otrok cepljen proti hepatitisu B že ob rojstvu.
Where a dose of hepatitis B vaccine is given at birth, Infanrix Penta 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 Infanrix Penta kot nadomestilo za dodatne odmerke cepiva proti hepatitisu B od starosti šestih tednov dalje.
3, 5 months) of Infanrix Penta a booster dose must be given at least 6 months after the last priming dose, preferably between 11 and 13 months of age.
Po cepljenju z dvema odmerkoma cepiva Infanrix Penta (v 3. in 5. mesecu starosti) mora otrok prejeti obnovitveni odmerek cepiva najmanj 6 mesecev po cepljenju z zadnjim odmerkom iz osnovne sheme cepljenja, po možnosti v starosti od 11 do 13 mesecev.
2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) of Infanrix Penta a booster dose must be given at least 6 months after the last priming dose and preferably before 18 months of age.
Po cepljenju s tremi odmerki cepiva Infanrix Penta (v 2., 3., 4. mesecu starosti; 3., 4., 5. mesecu starosti; 2., 4., 6. mesecu starosti) mora otrok prejeti obnovitveni odmerek cepiva najmanj 6 mesecev po cepljenju z zadnjim odmerkom iz osnovne sheme cepljenja, po možnosti preden dopolni 18 mesecev starosti.
Infanrix Penta is for deep intramuscular injection, preferably at alternating sites for subsequent injections.
Najbolje je, da naslednje odmerke damo na druga mesta.
In these circumstances pertussis vaccination should be discontinued and the vaccination should be continued with diphtheria-tetanus, hepatitis B and polio vaccines.
Uporaba Infanrix Penta je kontraindicirana, če je otrok prebolel encefalopatijo neznanega vzroka, ki se je pojavila v 7 dneh po predhodnem cepljenju s cepivom, ki je vsebovalo tudi komponento proti oslovskemu kašlju. V takšnih primerih moramo cepljenje proti oslovskemu kašlju opustiti, cepljenje pa nadaljevati s cepivi proti davici, tetanusu, hepatitisu B in otroški ohromelosti.
Temperature of ≥ 40.0 C within 48 hours, not due to another identifiable cause.
Zvišana telesna temperatura ≥ 40, 0 ºC v 48 urah, ki ji ni možno pripisati drugega vzroka.
Collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination.
Kolaps ali šoku podobno stanje (hipotonična- hiporesponzivna epizoda) v 48 urah po cepljenju.
Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination.
3 Stalen, neutolažljiv jok, ki traja ≥ 3 ure in se pojavi v 48 urah po cepljenju.
3 There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
V nekaterih okoliščinah, kot je visoka incidenca oslovskega kašlja, lahko pričakovana korist cepljenja prevlada nad možnim tveganjem.
Infanrix Penta 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 Infanrix Penta dajemo previdno, ker se pri njih po intramuskularnem injiciranju lahko pojavi krvavitev.
Infanrix Penta will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus or poliovirus.
Infanrix Penta ne prepreči bolezni, ki jih povzročijo drugi patogeni, ne pa Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, virus hepatitisa B ali poliovirus.
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 Infanrix Penta.
Anamneze vročinskih krčev družinske obremenjenosti z vročinskimi krči ali sindroma nenadne smrti dojenčka (SIDS- Sudden Infant Death Syndrome) ne uvrščamo med kontraindikacije za uporabo cepiva Infanrix Penta.
Clinical studies have demonstrated that Infanrix Penta can be administered simultaneously with Haemophilus influenzae type b vaccines.
Klinične študije so pokazale, da se Infanrix Penta lahko daje sočasno s cepivi proti okužbi z bakterijo Haemophilus influenzae tipa B.
In these clinical studies, the injectable vaccines were given at different injection sites.
V teh kliničnih študijah so bila cepiva ki jih injiciramo dana na različna mesta.
As Infanrix Penta is not intended for use in adults, adequate human data on use during pregnancy or lactation and adequate animal reproduction studies are not available.
Ker Infanrix Penta ni predviden za uporabo pri odraslih, ni podatkov o uporabi med nosečnostjo in dojenjem, prav tako ni na voljo ustreznih študij o vplivu na razmnoževanje pri živalih.
4 4.8 Undesirable effects
4. 8 Neželeni učinki
• Clinical trials
• Klinične študije